# K173020: OBA-MCP, Orthodontic Bracket Adhesive with MCP

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Jan 17, 2018 after 111 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911286: Pulpdent Orthodontic Bracket Adhesive, Pulpdent Corp. (1991) Summary page 4.
- K880393: Transbond Light Cured Orthodontic Adhesive, Unitek Corp. (1988) Summary page 4.
- K950556: Fuji Ortho LC, GC America, Inc. (1995) Summary page 4.

## Indications for use
PULPDENT OBA-MCP is a light-cure orthodontic adhesive composite for the direct and indirect bonding of orthodontic brackets. For dental professional use only.

Source page: https://510kreport.com/device/K173020
Methodology: https://510kreport.com/methodology