# K032597: Biscem GI

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Nov 4, 2003 after 74 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GC FujiCem: named in the summary without a submission number

## Most influential descendants
- K060701: Biscem Translucent, Biscem Opaque (2006), 4 descendants of its own
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own
- K171449: Metacem (2018), 1 descendant of its own
- K261166: Dia-Cem (2026), 0 descendants of its own
- K180802: Meta P&Bond (2018), 0 descendants of its own

## Indications for use
1. Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-to-metal and composite-to-metal varieties; 2. Luting resin crowns, bridges, inlays, onlays and veneers; 3. Luting metal or non-metal posts; 4. Luting orthodontic appliances; 5. Luting porcelain inlays.

Source page: https://510kreport.com/device/K032597
Methodology: https://510kreport.com/methodology