2010 Surviving and Thriving presented at OADL Fall 2010 Meeting

1. 2010 Surviving and Thriving presented at OADL Fall 2010 Meeting

2. Reference 2010 survey data based on December 2009 year end financial data 550 dental laboratory respondents around the country Data collected from April to June 2010 Study undergone by NADL and performed by Valmont Research, Inc.

3. Education

4. Employees (full-time)

5. Services

6. Years Lab in Existence

7. Owner/Manager Time Allocation

8. Owner�s Gross Income

9. Total Payroll - Technicians

10. Is Technician a CDT?

11. Years of Experience

12. Primary Job Function

13. How Paid

14. Hourly Wage

15. Annual Salary

16. Is Technician a CDT?

17. Years of Experience

18. Primary Job Function

19. How Paid

20. Hourly Wage

21. Annual Salary

22. Benefits Offered

23. Retirement Program

24. Retirement Matching

25. Health Insurance Plan

26. Health Cost Sharing - Employee

27. Health Cost Sharing - Dependents

28. PFM Crown � High Noble

29. PFM Crown � non-precious

30. All-ceramic Crown

31. Zirconia-based Crown

32. Dental Implant

33. Veneer

34. Inlay / Onlay

35. Sleep Apnea Device

36. Complete Maxillary Denture

37. Flexible Partial Denture

38. Soft Mouthguard

39. Total

40. Number of Clients

41. Net Profit

42. Outsource to Domestic Labs

43. Outsource to Overseas Labs

44. Dental Crowns Being Made Overseas 2006 Total Domestic Crown and Bridge Market was 33,458,641 units, manufactured offshore 5 million units (14%) 2008 Total Domestic Crown and Bridge Market was 37,214,886 units , manufactured offshore 7.5 million units (20%) 2010 Total Domestic Crown and Bridge Market estimated to finish at 39,476,350, manufactured offshore 8 million units (20%) Source on Total Units from iData Research 2010 Source on Number of Units Manufactured Offshore from NADL Cost of Doing Business Surveys, 2006, 2008,2010 (sample of 1,000 U.S. dental laboratories on offshore prodocution or outsourcing) as conducted by Valmont Resarch

45. What is new with FDA? FDA adding staff 1,300 new staff, primarily field operational personnel, but may include review staff Not all will be on inspections � many will be focused on import operations FDA embarking on a �Beyond our Borders� program to increase FDA�s presence internationally FDA offices in foreign countries China, India to begin, Europe, Central America and South America to follow IMP Investigational Medicinal ProductIMP Investigational Medicinal Product

46. What is new with FDA? China Offices Opened Beijing office in November 2008 Also offices in Shanghai and Guangzhou 13 people staff the 3 offices Eight (8) staffers are from the US (DHHS or FDA) Five (5) staffers are local hires Primary focus will be liaison with China�s State Food and Drug Administration (SFDA)

48. Import Volume History (All FDA Products)

49. FY 2009 Estimated Import Lines By Program Area

50. CDRH�s Import Safety Initiative Traveled to China to meet with China's SFDA Traveled to India to meet with the Government of India and India's medical device industry Presented Device 101 training in China and India Shared registration and listing data with SFDA Sponsored several weekly conference calls with our GHTF counterparts during the height of the heparin issue Developed CDRH Import Safety Plan. Strategies include: Creation of CDRH Import Staff Surveillance of the US market to identify illegal Imports ISO-13485 Training Courses Foreign trips to China and India

51. Center for Devices & Radiological Health

52. Office of Compliance Division of Enforcement A Dental, ENT & Ophthalmic Devices OB/GYN, Gastro & Urology Devices General Hospital Devices General Surgery Devices Division of Enforcement B Cardiovascular & Neurological Devices Diagnostic X-ray Devices Electronic Products & Devices Orthopedic, Physical Medicine & Anesthesiology Devices

53. Responsibilities During an FDA Inspection The Technical Manager will be the inspection coordinator and official respondent to an FDA 483. If unavailable, the Management representative will be the inspection coordinator. It is the receptionist responsibility to greet the investigator(s) and notify the appropriate personnel of the investigators arrival. It is executive management�s responsibility to attend the closing meeting and review documents presented by the investigator. Inspection team members will assist the inspection coordinator in obtaining information and required records and taking notes.

54. Procedure FDA investigators are not allowed to bring cameras or recording devices into the facility without a court order. Employees shall not acknowledge, read, initial or sign any affidavits presented by the investigator. If document/records provided to the investigator contain confidential information, clearly mark the document confidential and inform the investigator of the confidential information. Copies of requested documents may be supplied free of charge so long as the quantity is reasonable. The following documents are not subject to review by the FDA: financial data (except published data available to the public); sales data (except published data available to the public); pricing data (except published data available to the public); personnel data (except training, technical qualifications and organization structure); legal correspondence; litigation or liability files; results of management review, results of internal audits, results of customer audits, results of supplier audits and associated corrective actions. Samples may only be given upon approval from the Technical Manager, General Manager or RVP. If the investigator disagrees with company policies and procedures, contact legal counsel for clarification.

55. Investigator Reception The receptionist is usually the first person to greet the investigator. Regardless of where the FDA investigator appears he/she is escorted to the receptionist. Request the investigator to sign in to the visitor�s log. Politely ask the investigator to have a seat in the reception area. Do not let the investigator(s) leave the reception area unescorted. Notify the Technical Manager and Management Representative. Assist the Technical Manager in contacting those members of the organization who will make up the inspection team. Prepare a meeting room for the inspection and inspection team. Remove any documents, records, samples and confidential information. After the inspection coordinator has received the inspector, inform the company officers of the visit.

56. Notice of Inspection After the inspection team has been assembled in the meeting room, the inspection coordinator will receive the investigator and provide the inspector with a visitor�s badge. Escort the investigator to the meeting room. The inspection coordinator will ask for identification Ask the reason for the visit and estimated length of time, and draw up an agenda for the day. Obtain a written NOTICE OF INSPECTION � FDA 482. The inspection coordinator will advise the inspector of company policies & regulations, such as, normal business hours, safety requirements, camera policy, recoding policy, etc. The inspection coordinator will ask the investigator to point out any issues or potential observations at the time they are observed in order to provide the company an opportunity to investigate such issues. The inspection coordinator will provide the background information requested by the investigator regarding history of the business, sales volumes, products, organization and facility layout.

57. Inspection Guidelines Keep accurate and detailed notes of the inspection, names, department areas, questions asked, responses, documents and records reviewed and concerns. Visit only those areas necessary to perform the inspection. Bring requested documents and records to the meeting room as expeditiously as possible. Be cooperative and courteous. Keep brief and be factual. Do not volunteer information beyond the scope of the question. Do not provide personal opinion. Appropriate personnel should be available to respond to specific questions in their area of responsibility. If the inspection extends beyond one day, each successive day should begin with a meeting to review the proposed agenda and complete any business left unfinished from the previous day. At the conclusion of each day, the investigator should be asked whether any items require clarification.

58. Documents Supply the investigator with only specific documents and records requested. Do not allow the investigator to randomly search through company files. If the investigator requests copies of documents they should be those specific to the nature of the investigation. Make a duplicate copy of each document provided to the investigator for the company inspection file and mark �Copy Removed by FDA�.

59. Product Samples/Samples of Labeling If the inspector request samples, ask the purpose. Usually samples of materials or working progress are not given since they do not represent finished product provided to the end user. Seek further advice from legal counsel. If sample requested are customer property, contact the customer. When samples are given, the inspector must provide an FDA 484 Sample Request Form. Where possible a duplicate sample should be maintained and mark �Duplicate Sample Removed by FDA�.

60. Closing Meeting The inspection coordinator and members of the inspection team will attend the closing meeting. Additional participants from the audit may be in attendance as well as company officers. Discuss the results of the investigation and observations noted on FDA 483. An FDA 484 is issued when the investigator has identified nonconformances against the regulations. Upon presentation by the investigator of any inspection observations clear up any confusion or misunderstandings. If observations are inaccurate, present supporting information and objective evidence to the investigator. Have the investigator correct any errors on the FDA 483. If corrective action has already been implemented, provide information and evidence to the inspector. Ensure that the investigator indicates on the FDA 483 which observations were corrected during the course of the inspection. When an FDA 483 is issued, inform the investigator that a formal response will be sent to the district office.

61. Inspection Follow Up A summary of the inspection will be documented by the inspection coordinator in a timely manner and distributed to executive management. The report should include: purpose of the visit, copies of documents received from the investigator, questions asked and answers provided, records examined, copies of documents and samples provide, products inspected, any relevant comments pertaining to the audit. If an FDA 483 was issued, a meeting will be convened to discuss the company�s response to the FDA. The Technical Manager will provide a written response to the FDA within the required time period. The response will include corrective action taken or planned and a timeframe for implementation. The response will be reviewed by the Company President and legal counsel prior to submission to the FDA District Office. Issue Corrective Action Request for each observation and process per QSP 6. When FDA sends a copy of the Establishment Inspection Report (EIR), review it carefully and notify FDA District Office of any discrepancies. The Technical Manager will collect all inspection documentation and retain per QSP 13, Record Retention.