# K061481: Grengloo

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corp.
- Decided: Jul 6, 2006 after 37 days
- Product code: DYH (Adhesive, Bracket And Tooth Conditioner, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Blugico: named in the summary without a submission number

## Recalls of this device
- Oct 31, 2007 · Not classified · Z-0916-2008: Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.

## Indications for use
Grengloo is a light-cured orthodontic bonding adhesive and is intended to be used for the attachment of orthodontic appliances to teeth.

Source page: https://510kreport.com/device/K061481
Methodology: https://510kreport.com/methodology