The following data is part of a premarket notification filed by Robert A James with the FDA for Spiral Lock Dental Implant System.
| Device ID | K926100 |
| 510k Number | K926100 |
| Device Name: | SPIRAL LOCK DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ROBERT A JAMES 11222 WALLABY COURT San Diego, CA 92128 |
| Contact | Alan Donald |
| Correspondent | Alan Donald ROBERT A JAMES 11222 WALLABY COURT San Diego, CA 92128 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-03 |
| Decision Date | 1994-05-23 |