The following data is part of a premarket notification filed by Buck Medical Research with the FDA for Bmr Dental Implant System, Model 3.3xx, Either Ha Or Tps Coated, 3.308, 3.310,3.312, 3.314 3.316.
| Device ID | K010343 |
| 510k Number | K010343 |
| Device Name: | BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BUCK MEDICAL RESEARCH 2811 LEMMON AVE., SUITE 201 Dallas, TX 75204 |
| Contact | Rebecca Ellis |
| Correspondent | Rebecca Ellis BUCK MEDICAL RESEARCH 2811 LEMMON AVE., SUITE 201 Dallas, TX 75204 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-05 |
| Decision Date | 2001-02-14 |