Disk, Abrasive
FDA product code EHJ · Class I (low risk) · 21 CFR 872.6010 · Dental
4510(k) clearances
0PMA approvals
2recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K911111 | Micromills, Patriots, Alpha Gold DiamondsEHJ · Traditional | Vermont Diamond Instruments | 11/19/1991SE |
| K873002 | Min-IdentoflexEHJ · Traditional | Centrix, Inc. | 08/17/1987SE |
| K790640 | Howmedica Brass Center DiscEHJ · Traditional | E.C. Moore Co. | 05/01/1979SE |
| K771658 | IdentoflexEHJ · Traditional | Cavitron Corp. | 09/12/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1689-2026 Class II | Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment. | Ultradent Products, Inc. | 01/28/2026Open, Classified |
| Z-2373-2016 Class II | OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459…After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol… | Ivoclar Vivadent, Inc. | 07/11/2016Terminated |