The following data is part of a premarket notification filed by Doceram Medical Ceramics Gmbh with the FDA for Nacera Pearl.
| Device ID | K143071 |
| 510k Number | K143071 |
| Device Name: | Nacera Pearl |
| Classification | Powder, Porcelain |
| Applicant | DOCERAM MEDICAL CERAMICS GMBH HESSLINGSWEG 65-67 Dortmund, Nrw, DE D-44309 |
| Contact | Stefan Drude |
| Correspondent | Stefan Drude DOCERAM MEDICAL CERAMICS GMBH HESSLINGSWEG 65-67 Dortmund, Nrw, DE D-44309 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-27 |
| Decision Date | 2015-06-26 |
| Summary: | summary |