# K200555: Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)

- Pathway: 510(k) (Traditional)
- Applicant: Prevest Denpro Limited
- Decided: May 13, 2021 after 436 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 5.

## Indications for use
Micron Bioactive Class III and V, Restoration of cervical erosions and root surface caries, Core buildup, Base/Liner Class I, limited Class I, temporary fillings Restoration of primary teeth Micron Superior Shades Al, A2, A3 Class 111, Class V, limited Class I Restoration of primary teeth, Core buildup Micron Superior Capsules Shades A1, A2, A3 Class III, Class V., limited Class | Restoration of primary teeth, Core buildup Micron Luting Cementation of all types of metal, porcelain fused to metal, and resin crowns, inlays, onlays, and bridges Cementation of orthodontic bands Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns Basc/Liner Micron Dentin Conditioner Dentin pre-treatment prior to filling with glass ionomer cement

Source page: https://510kreport.com/device/K200555
Methodology: https://510kreport.com/methodology