Part B: SUPPLEMENTARY INFORMATION
ADA / ANSI , . () |
| Addresses of Standards Organizations: |
| American Dental Association (ADA) |
| 211 East Chicago Avenue |
| Chicago, IL 60611-2678 |
| |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
|
| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
|
| (2) | OFFICE OF COMPLIANCE (OC) | | |
|
|
| Devices Affected: |
|
| Processes Affected: |
|
| Type of Standard: |
| National, Vertical |
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3820 |
Resin, Root Canal Filling |
Class 2 |
KIF |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3840 |
Point, Silver, Endodontic |
Class 1 |
EKL |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3850 |
Gutta-Percha |
Class 1 |
EKM |
| |
|
| FDA Technical Contact: |
| Michael Adjodha |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2606 |
| Silver Spring MD 20993 |
| 301/796-6276 |
| Email: michael.adjodha@fda.hhs.gov |
|
|
