The following data is part of a premarket notification filed by The Stern Metals Co., Inc. with the FDA for Impla-med Ucla Type Abutments,screwdriver,reamer,l.
Device ID | K933193 |
510k Number | K933193 |
Device Name: | IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L |
Classification | Implant, Endosseous, Root-form |
Applicant | THE STERN METALS CO., INC. 23 FRANK MOSSBERG DR. Attleboro, MA 02703 |
Contact | Raymond Walton |
Correspondent | Raymond Walton THE STERN METALS CO., INC. 23 FRANK MOSSBERG DR. Attleboro, MA 02703 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-30 |
Decision Date | 1994-03-07 |