KZO
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ink, Arch Tracing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3150
- Medical specialty
- Dental
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| THE GNATHOMETER-M (K810972) | Bauer, Cheng & Associates, Inc. | 1981-05-05 |
| GOTHIC ARCH TRACING (K771176) | Dentsply Intl. | 1977-08-16 |
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Every clearance here is in the API, with alerts when new ones post.