The following data is part of a premarket notification filed by Implant Support Systems, Inc. with the FDA for Dalla Bona Ball & Sockey Attach. Snap Type Precis.
| Device ID | K921764 |
| 510k Number | K921764 |
| Device Name: | DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECIS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT SUPPORT SYSTEMS, INC. 4790 IRVINE BLVD. #105-137 Irvine, CA 92720 |
| Contact | Brian Hill |
| Correspondent | Brian Hill IMPLANT SUPPORT SYSTEMS, INC. 4790 IRVINE BLVD. #105-137 Irvine, CA 92720 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-14 |
| Decision Date | 1992-11-03 |