The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Vectors Temporary Anchorage System.
| Device ID | K061230 |
| 510k Number | K061230 |
| Device Name: | VECTORS TEMPORARY ANCHORAGE SYSTEM |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | SYBRON DENTAL SPECIALTIES 100 BAYVIEW CIRCLE SUITE 6000 Newport Beach, CA 92660 -8915 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES 100 BAYVIEW CIRCLE SUITE 6000 Newport Beach, CA 92660 -8915 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-02 |
| Decision Date | 2006-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889989000235 | K061230 | 000 |
| 10889989000112 | K061230 | 000 |
| 10889989000105 | K061230 | 000 |
| 10889989000099 | K061230 | 000 |
| 10889989000082 | K061230 | 000 |
| 10889989000075 | K061230 | 000 |
| 10889989000051 | K061230 | 000 |
| 10889989000044 | K061230 | 000 |
| 10889989000013 | K061230 | 000 |
| 10889989000129 | K061230 | 000 |
| 10889989000136 | K061230 | 000 |
| 10889989000143 | K061230 | 000 |
| 10889989000228 | K061230 | 000 |
| 10889989000211 | K061230 | 000 |
| 10889989000204 | K061230 | 000 |
| 10889989000198 | K061230 | 000 |
| 10889989000181 | K061230 | 000 |
| 10889989000174 | K061230 | 000 |
| 10889989000167 | K061230 | 000 |
| 10889989000150 | K061230 | 000 |
| 10889989000006 | K061230 | 000 |