Regulatory Compliance Notice

Federal Compliance - Disclosure

Knight Dental Group, Inc. is in compliance with the Food, Drug and Cosmetic Act of 1978 as referenced in Food and Drug Administration (FDA) (Code for Federal Regulations (CFR), Chapter 21, Section 801 as it relates to disclosure of manufacture of origin and patient contact materials.

Federal Compliance – GMP’S

Knight Dental Group, Inc. is in compliance with all Current Good Manufacturing Practices (CGMP) as outlined in the Food and Drug Administration (FDA) Code of Federal Regulations (CFR), Chapter 21, section 820, as it relates to design, manufacture, packaging, labeling and servicing of all finished devices intended for human use. Knight Dental Group is a ISO 13485 certified Medical Device Quality Management System (US 12/82593) and a Dental Appliance Manufacturing Audit System (DAMAS) quality certified (#0505/0006) manufacturer of dental devices and is subject to third party audits.

State Compliance Notice (in specific states that have statutory requirements)

Florida

Knight Dental Group, Inc. is a registered dental laboratory in the state of Florida (#DL 1209) and complies with all statutes as outlined in the Dental Practice Act, Chapter 466.032 and by the Department of Health, Board of Dentistry.

South Carolina

Knight Dental Group, Inc. is a registered dental laboratory in the state of South Carolina (#514) and complies with all statutes as outlined in the Dental Practice Act, Chapter 466.032 and in accordance to the statutory authority 1976, Code 40-15-10.

Texas

Knight Dental Group, Inc. is a registered dental laboratory in the state of Texas (#3117) and complies with all statutes as outlined in the Dental Practice Act, Title 3, Health Professional, Subtitle D Dentistry, and Chapter 266.