# K192682: Orthocem, Ortho Bite

- Pathway: 510(k) (Traditional)
- Applicant: Dentscare Ltda
- Decided: Aug 14, 2020 after 323 days
- Product code: DYH (Adhesive, Bracket And Tooth Conditioner, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3750
- 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 K880393 (1988). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880393: Transbond Light Cured Orthodontic Adhesive, Unitek Corp. (1988) Summary page 5.
- K924151: Bisco D/C Resinomer, Bisco, Inc. (1992) Summary page 5.

## Most influential descendants
- K210349: TKO Composite Bite Turbo Gel (2021), 0 descendants of its own

## Indications for use
Orthocem Cementation of metal, ceramic or polycarbonate brackets or tubes to enamel surface. Ortho bite The product is indicated for cementing orthodontic bands and is also suitable for temporary dental disocclusion during orthodontic treatment.

Source page: https://510kreport.com/device/K192682
Methodology: https://510kreport.com/methodology