The following data is part of a premarket notification filed by Implant Direct Llc with the FDA for Screwindirect Dental Implants.
Device ID | K080633 |
510k Number | K080633 |
Device Name: | SCREWINDIRECT DENTAL IMPLANTS |
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 | 2008-03-05 |
Decision Date | 2008-07-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10841307104742 | K080633 | 000 |
10841307104735 | K080633 | 000 |
10841307104711 | K080633 | 000 |
10841307104704 | K080633 | 000 |
10841307103615 | K080633 | 000 |
10841307103608 | K080633 | 000 |
10841307103592 | K080633 | 000 |
10841307103585 | K080633 | 000 |