The following data is part of a premarket notification filed by Pacific Dental Corp. with the FDA for J. Morita Flex M-3 Torx Hardpiece.
| Device ID | K821739 |
| 510k Number | K821739 |
| Device Name: | J. MORITA FLEX M-3 TORX HARDPIECE |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | PACIFIC DENTAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-14 |
| Decision Date | 1982-06-25 |