The following data is part of a premarket notification filed by Suncoast Dental Corp. with the FDA for R & S Series Implants.
Device ID | K811923 |
510k Number | K811923 |
Device Name: | R & S SERIES IMPLANTS |
Classification | Implant, Endosseous, Root-form |
Applicant | SUNCOAST DENTAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-02 |
Decision Date | 1981-07-24 |