The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Implant Bar.
| Device ID | K120858 |
| 510k Number | K120858 |
| Device Name: | IMPLANT BAR |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DR., ST P Irvine, CA 92612 |
| Contact | Kathleen Dragovich |
| Correspondent | Kathleen Dragovich PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DR., ST P Irvine, CA 92612 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-21 |
| Decision Date | 2012-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745701054COM01540 | K120858 | 000 |
| D745701051COM02620 | K120858 | 000 |
| D745701051COM02610 | K120858 | 000 |
| D745701048COM00670 | K120858 | 000 |
| D745701047COM02040 | K120858 | 000 |
| D745701050COM00320 | K120858 | 000 |
| D745701050COM00310 | K120858 | 000 |