The following data is part of a premarket notification filed by Sabre-k Ltd. with the FDA for Kurer Crown Saver K4 Anchor System-the Universal Kit, Kurer Standard K4 Anchor System- The Ready Core Kit, Kurer Fin-loc.
| Device ID | K983161 |
| 510k Number | K983161 |
| Device Name: | KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC |
| Classification | Post, Root Canal |
| Applicant | SABRE-K LTD. GOLF ROAD, HALE ALTRINCHAM Cheshire Wa 15 8ah, GB |
| Contact | Steven Buckley |
| Correspondent | Steven Buckley SABRE-K LTD. GOLF ROAD, HALE ALTRINCHAM Cheshire Wa 15 8ah, GB |
| Product Code | ELR |
| CFR Regulation Number | 872.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-09 |
| Decision Date | 1998-09-30 |