The following data is part of a premarket notification filed by Sterngold with the FDA for Sterngold Acid Etch Dental Implant System.
Device ID | K023580 |
510k Number | K023580 |
Device Name: | STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | STERNGOLD 5 WHITCOMB AVE. Ayer, MA 01432 |
Contact | Pamela Papineau |
Correspondent | Pamela Papineau STERNGOLD 5 WHITCOMB AVE. Ayer, MA 01432 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-24 |
Decision Date | 2003-01-17 |
Summary: | summary |