The following data is part of a premarket notification filed by Aesculap Instruments Corp. with the FDA for Handpiece, Dental.
| Device ID | K801888 |
| 510k Number | K801888 |
| Device Name: | HANDPIECE, DENTAL |
| Classification | Drill, Dental, Intraoral |
| Applicant | AESCULAP INSTRUMENTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DZA |
| CFR Regulation Number | 872.4130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-28 |
| Decision Date | 1980-08-20 |