The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Cylinder Dental Implant.
| Device ID | K954605 |
| 510k Number | K954605 |
| Device Name: | ACE CYLINDER DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Contact | J. Edward Carchidi |
| Correspondent | J. Edward Carchidi ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-04 |
| Decision Date | 1996-06-05 |