# K101869: Proglass Cements (One, Two Two LC, Nine, Plus, Silver)

- Pathway: 510(k) (Traditional)
- Applicant: Silmet, Ltd.
- Decided: Sep 29, 2010 after 89 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: 1 generation back to K946100 (1995). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980695: FUJI I, GC America, Inc. (1998) Summary page 1.
- K980682: Fuji II, GC America, Inc. (1998) Summary page 1.
- K961584: Fuji II LC (Improved), GC America, Inc. (1996) Summary page 1.
- K961448: Fuji IX GP, GC America, Inc. (1996) Summary page 1.
- K946100: Fuji Duet, GC America, Inc. (1995) Summary page 1.
- K984505: Miracle Mix Powder/Liquid, GC America, Inc. (1999) Summary page 1.

## Most influential descendants
- K210473: Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) (2021), 0 descendants of its own
- K200555: Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) (2021), 0 descendants of its own
- K123824: Vitro Fil LC (2013), 0 descendants of its own

## Indications for use
ProGlass One: 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 ProGlass Two: Class III, V and limited class I cavities Restoration of primary teeth Core Build Up ProGlass Two LC: Class III and V restorations Restoration of Cervical erosions and root surface canies Core Build Up Base/Liner ProGlass Nine: 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 ProGlass Plus: Metal-based restorations Ceramic inlays Reinforced ceramic crowns and bridges All kinds of acrylic/resin crowns, inlays, onlays and bridges ProGlass Silver: Class I, limited Class II, temporary fillings Restoration of primary teeth Core Build Up Base/Liner

Source page: https://510kreport.com/device/K101869
Methodology: https://510kreport.com/methodology