The following data is part of a premarket notification filed by Dental Power, Inc. with the FDA for Versadowel Post System.
Device ID | K940680 |
510k Number | K940680 |
Device Name: | VERSADOWEL POST SYSTEM |
Classification | Post, Root Canal |
Applicant | DENTAL POWER, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -5600 |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein DENTAL POWER, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -5600 |
Product Code | ELR |
CFR Regulation Number | 872.3810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-10 |
Decision Date | 1994-03-15 |