The following data is part of a premarket notification filed by Otc/america with the FDA for Pure Titanium Screw-type For Dental Implant.
| Device ID | K860653 |
| 510k Number | K860653 |
| Device Name: | PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-21 |
| Decision Date | 1986-04-17 |