The following data is part of a premarket notification filed by Contour Healer, Llc with the FDA for Contour Healer.
| Device ID | K112099 |
| 510k Number | K112099 |
| Device Name: | CONTOUR HEALER |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | CONTOUR HEALER, LLC 1117 DITCHLEY ROAD Virginia Beach, VA 23451 |
| Contact | Allen Hardin White |
| Correspondent | Allen Hardin White CONTOUR HEALER, LLC 1117 DITCHLEY ROAD Virginia Beach, VA 23451 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-22 |
| Decision Date | 2012-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859598007126 | K112099 | 000 |
| 00859598007157 | K112099 | 000 |
| 90859598007136 | K112099 | 000 |
| 00859598007003 | K112099 | 000 |
| 00859598007010 | K112099 | 000 |
| 00859598007027 | K112099 | 000 |
| 00859598007034 | K112099 | 000 |
| 00859598007041 | K112099 | 000 |
| 00859598007058 | K112099 | 000 |
| 00859598007065 | K112099 | 000 |
| 00859598007072 | K112099 | 000 |
| 00859598007089 | K112099 | 000 |
| 00859598007096 | K112099 | 000 |
| 00859598007102 | K112099 | 000 |
| 00859598007119 | K112099 | 000 |
| 00859598007140 | K112099 | 000 |