K801888 is an FDA 510(k) clearance for the HANDPIECE, DENTAL. This device is classified as a Drill, Dental, Intraoral (Class I - General Controls, product code DZA).
Submitted by Aesculap Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980, 23 days after receiving the submission on July 28, 1980.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4130.
| 510(k) Number | K801888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 1980 |
| Decision Date | August 20, 1980 |
| Days to Decision | 23 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 |