# K101064: Bredent Novo.Lign a/ Bredent Novo.Lign P

- Pathway: 510(k) (Traditional)
- Applicant: Bredent GmbH & Co. KG
- Decided: Sep 14, 2010 after 151 days
- Product code: ELM (Denture, Plastic, Teeth)
- Device class: 2
- Regulation: 21 CFR 872.3590
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K962456 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962456: SR Antaris Anterior Teeth/SR Postaris Posterior Teeth, Ivoclar North America, Inc. (1996) Summary page 1.

## Indications for use
The bredent novo.lign A / novo.lign P are preformed plastic denture teeth as a prefabricated device, composed of materials such as polymethylmethacrylat and methylmethacrylat that are intended for use as veneers. The bredent novoiign A / novo.lign P are used for temporary or partial or full dentures. Permanent veneering: * telescopic and conical crowns * CoCr clasp restorations * crowns and bridges * implant-supported restorations * coverdenture techniques Veneer-up: * selection of esthetic shade, shape and tooth position remporary restorations: * laboratory-made temporaries based on impression and wax-up * veneer on temporary abutments after placement of the implant The devices are offered in non-sterile condition.

Source page: https://510kreport.com/device/K101064
Methodology: https://510kreport.com/methodology