The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Sds 3.75mm Screw Dental Implant.
| Device ID | K002075 |
| 510k Number | K002075 |
| Device Name: | ACE SDS 3.75MM SCREW DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
| Contact | J. Edward Carchidi |
| Correspondent | J. Edward Carchidi ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-10 |
| Decision Date | 2001-02-02 |