The following data is part of a premarket notification filed by Implant Direct Llc with the FDA for Reactive Dental Implant System.
| Device ID | K080713 |
| 510k Number | K080713 |
| Device Name: | REACTIVE DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. Calabasas Hills, CA 91301 |
| Contact | Thomas Gottenbos |
| Correspondent | Thomas Gottenbos IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. Calabasas Hills, CA 91301 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-13 |
| Decision Date | 2008-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307103752 | K080713 | 000 |
| 10841307103745 | K080713 | 000 |
| 10841307103738 | K080713 | 000 |
| 10841307103721 | K080713 | 000 |
| 10841307103714 | K080713 | 000 |
| 10841307103707 | K080713 | 000 |
| 10841307103691 | K080713 | 000 |
| 10841307103684 | K080713 | 000 |
| 10841307103622 | K080713 | 000 |