The following data is part of a premarket notification filed by Bredent Gmbh & Co.kg with the FDA for Bredent Novo.lign A/ Bredent Novo.lign P.
| Device ID | K101064 |
| 510k Number | K101064 |
| Device Name: | BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P |
| Classification | Denture, Plastic, Teeth |
| Applicant | BREDENT GMBH & CO.KG SCHWARZWALDSTRASSE 5 Tuttlingen, Bawu, DE 78532 |
| Contact | Andrea Pecsi |
| Correspondent | Andrea Pecsi BREDENT GMBH & CO.KG SCHWARZWALDSTRASSE 5 Tuttlingen, Bawu, DE 78532 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-16 |
| Decision Date | 2010-09-14 |
| Summary: | summary |