The following data is part of a premarket notification filed by Clinician's Choice Dental Products, Inc. with the FDA for Template And Counter-fit.
| Device ID | K081017 |
| 510k Number | K081017 |
| Device Name: | TEMPLATE AND COUNTER-FIT |
| Classification | Material, Impression |
| Applicant | CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. 1980 HYDE PARK ROAD London, Ontario, CA N6h 5l9 |
| Contact | Jeanette Smith |
| Correspondent | Jeanette Smith CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. 1980 HYDE PARK ROAD London, Ontario, CA N6h 5l9 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-09 |
| Decision Date | 2008-08-04 |