The following data is part of a premarket notification filed by L.c. Dental with the FDA for Lc Dental Hand Instrument.
| Device ID | K935217 |
| 510k Number | K935217 |
| Device Name: | LC DENTAL HAND INSTRUMENT |
| Classification | Burnisher, Operative |
| Applicant | L.C. DENTAL 503-A VANDELL WAY Campbell, CA 95008 |
| Contact | Lars Callne |
| Correspondent | Lars Callne L.C. DENTAL 503-A VANDELL WAY Campbell, CA 95008 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-26 |
| Decision Date | 1994-01-05 |