The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Dental Abrasive Device.
| Device ID | K780811 |
| 510k Number | K780811 |
| Device Name: | DENTAL ABRASIVE DEVICE |
| Classification | Point, Abrasive |
| Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EHL |
| CFR Regulation Number | 872.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-05-18 |
| Decision Date | 1978-06-22 |