# K142130: Oral Bond

- Pathway: 510(k) (Traditional)
- Applicant: Steiner Laboratories
- Decided: Jun 6, 2016 after 672 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
Longest line of descent: 3 generations back to K810545 (1981). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071484: Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040, Glustitch, Inc. (2007) Summary page 6.

## Indications for use
Oral Bond is indicated to be used as an adjunct to temporally assist in securing periodontal dressings.

Source page: https://510kreport.com/device/K142130
Methodology: https://510kreport.com/methodology