The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Np-cast Abutment System.
| Device ID | K121843 |
| 510k Number | K121843 |
| Device Name: | NP-CAST ABUTMENT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR Fairless Hills, PA 19030 |
| Contact | Patrick Lim |
| Correspondent | Patrick Lim OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR Fairless Hills, PA 19030 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-25 |
| Decision Date | 2012-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800000921426 | K121843 | 000 |
| 08800000921327 | K121843 | 000 |
| 08800000921334 | K121843 | 000 |
| 08800000921341 | K121843 | 000 |
| 08800000921358 | K121843 | 000 |
| 08800000921365 | K121843 | 000 |
| 08800000921372 | K121843 | 000 |
| 08800000921389 | K121843 | 000 |
| 08800000921396 | K121843 | 000 |
| 08800000921402 | K121843 | 000 |
| 08800000921419 | K121843 | 000 |
| 08800000921310 | K121843 | 000 |