The following data is part of a premarket notification filed by Miltex, Inc. with the FDA for Dental Instruments - Cutting Instrument.
| Device ID | K823326 |
| 510k Number | K823326 |
| Device Name: | DENTAL INSTRUMENTS - CUTTING INSTRUMENT |
| Classification | Instrument, Hand, Calculus Removal |
| Applicant | MILTEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELA |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-08 |
| Decision Date | 1982-11-24 |