The following data is part of a premarket notification filed by Keystone Dental, Inc. with the FDA for Olympus Dental Implant System.
| Device ID | K071070 |
| 510k Number | K071070 |
| Device Name: | OLYMPUS DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | KEYSTONE DENTAL, INC. 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson KEYSTONE DENTAL, INC. 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-16 |
| Decision Date | 2007-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D768T306030 | K071070 | 000 |