The following data is part of a premarket notification filed by Ace Surgical Supply Company Inc. with the FDA for Ace Trimark Tricam Dental Implant.
| Device ID | K103790 |
| 510k Number | K103790 |
| Device Name: | ACE TRIMARK TRICAM DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ACE SURGICAL SUPPLY COMPANY INC. 1034 PEARL ST. Brockton, MA 02401 |
| Contact | Denise Williams |
| Correspondent | Denise Williams ACE SURGICAL SUPPLY COMPANY INC. 1034 PEARL ST. Brockton, MA 02401 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-27 |
| Decision Date | 2011-08-18 |
| Summary: | summary |