The following data is part of a premarket notification filed by Otc/america with the FDA for Osseodent Drilling System.
| Device ID | K862110 |
| 510k Number | K862110 |
| Device Name: | OSSEODENT DRILLING SYSTEM |
| Classification | Handpiece, Rotary Bone Cutting |
| Applicant | OTC/AMERICA 37 WALNUT ST. Wellesley Hills, MA 02181 |
| Contact | Ralph Green |
| Correspondent | Ralph Green OTC/AMERICA 37 WALNUT ST. Wellesley Hills, MA 02181 |
| Product Code | KMW |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-03 |
| Decision Date | 1986-08-07 |