# K082449: Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012

- Pathway: 510(k) (Special)
- Applicant: Bisco, Inc.
- Decided: Sep 25, 2008 after 31 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.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K061700: Neotract Anchor, Neotract, Inc. (2006). Our reading of the summary gave K061700, FDA’s number for Neotract Anchor (Neotract, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “BisCem”. Kept off the family tree.

## Most influential descendants
- K231552: Dia-Cem (2023), 1 descendant of its own
- K161256: TheraCem (2016), 1 descendant of its own
- K254201: Any-Cem (2026), 0 descendants of its own
- K261166: Dia-Cem (2026), 0 descendants of its own
- K193260: U-Cem Premium & MAZIC Cem (2020), 0 descendants of its own

## Indications for use
1. Luting metal crowns, bridges, inlays, 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/K082449
Methodology: https://510kreport.com/methodology