K901097 is an FDA 510(k) clearance for the FILLOCK REAMER. This device is classified as a Drill, Dental, Intraoral (Class I - General Controls, product code DZA).
Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on April 25, 1990, 49 days after receiving the submission on March 7, 1990.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4130.
| 510(k) Number | K901097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1990 |
| Decision Date | April 25, 1990 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DZA — Drill, Dental, Intraoral |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4130 |