# K060701: Biscem Translucent, Biscem Opaque

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: May 15, 2006 after 60 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032597 (2003). 1 ancestor in all.
4 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)
- K032597: Biscem GI, Bisco, Inc. (2003) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Apr 28, 2008 · Not classified · Z-1696-2008: During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified t
- Apr 28, 2008 · Not classified · Z-1697-2008: During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified t

## 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/fiber posts; 4. Luting orthodontic appliances; 5. Luting porcelain inlays, onlays, crowns, and veneers (includes alumina and zirconia).

Source page: https://510kreport.com/device/K060701
Methodology: https://510kreport.com/methodology