# K210473: Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)

- Pathway: 510(k) (Traditional)
- Applicant: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
- Decided: Nov 2, 2021 after 258 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K946100 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101869: Proglass Cements (One, Two Two LC, Nine, Plus, Silver), Silmet, Ltd. (2010) Summary page 6.

## Indications for use
Nova Glass L -Cementation of all types of metal, porcelain fused to metal, resin crowns, inlays, onlays & bridges -Cementation of orthodontic bands -Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns -Base/liner Nova Glass F -Class III, V and limited class I cavities -Restoration of primary teeth -Core Build Up Nova Glass LC -Class III and V restorations -Restoration of Cervical erosions and root surface caries -Core build up -Base/liner Nova Glass BF -Class I & II cavities -Decidious teeth: final restorative for Class I, II and V -Long term restorative in non-load bearing areas of Class I, II and V -Intermediate restorative & sandwich material for heavy stress bearing -Core build up material Nova Glass L Plus -Metal-based restorations -Ceramic inlays -Reinforced ceramic crowns and bridges -All kinds of acrylic/resin crowns, inlays, onlays and bridges

Source page: https://510kreport.com/device/K210473
Methodology: https://510kreport.com/methodology