# Ormco Corp.

- Location (FDA's records): Glendora, CA
- FDA decisions: 46 (1978–2025): 46 510(k) clearances
- Names in FDA's records: Ormco Corp. (40); Ormco Corporation (6)
- Product codes: DYH (10), DYW (9), EJF (8), DZB (4), NJM (3), NXC (3), NOF (2), EKS (1), ECO (1), EJT (1), ECR (1), DZC (1)
- 510(k) review time since 2016: median 90 days, against 97 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 17 (6 its own); citations of its devices by later devices: 17 (6 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cadent, Inc.: 2 (https://510kreport.com/company/cadent)
- Wuxi EA Medical Instruments Technologies Limited.: 2 (https://510kreport.com/company/wuxi-ea-medical-instruments-technologies)
- American Orthodontics: 1 (https://510kreport.com/company/american-orthodontics)
- Brontes Technologies: 1 (https://510kreport.com/company/brontes-technologies)
- 3M Unitek: 1 (https://510kreport.com/company/3m-unitek)
- Biomet 3i, Inc.: 1 (https://510kreport.com/company/biomet-3i)
- 3M Espe AG: 1 (https://510kreport.com/company/3m-espe)
- Unitek Corp.: 1 (https://510kreport.com/company/unitek)

## Firms that cite its devices most
- Danville Materials, Inc.: 1 (https://510kreport.com/company/danville-materials)
- Smylio, Inc.: 1 (https://510kreport.com/company/smylio)
- World Class Technology Corporation: 1 (https://510kreport.com/company/world-class-technology)
- Signature Orthodontics: 1 (https://510kreport.com/company/signature-orthodontics)
- Ortho Organizers, Inc.: 1 (https://510kreport.com/company/ortho-organizers)
- Apexum, Ltd.: 1 (https://510kreport.com/company/apexum)
- Stick Tech, Ltd.: 1 (https://510kreport.com/company/stick-tech)
- Biomers Product, LLC: 1 (https://510kreport.com/company/biomers-product)

## Its most-cited devices
- K081415: Damon 4CLEAR (2008), cited by 4
- K941015: Ormco System 1+ (TM) (1994), cited by 2
- K121524: Insignia (2012), cited by 2
- K203737: Spark Clear Aligner System (2021), cited by 2
- K122065: Digital Impression System for Orthodontic Use (2013), cited by 1
- K062856: TF Rotary Nickel Titanium File (2006), cited by 1

## Recent decisions
- K250487: SparkTM Clear Aligner System (Feb 20, 2025)
- K250015: Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive (Jan 3, 2025)
- K240501: Spark™ Clear Aligner System (Oct 11, 2024)
- K203737: Spark Clear Aligner System (Mar 22, 2021)
- K172845: Symetri Clear (Jan 31, 2018)
- K171844: Inspire ICE aka Inspire ICE Clear Brackets (Jul 18, 2017)
- K141611: Lythos Digital Impression System (Dec 5, 2014)
- K123118: Insignia Digicast (Mar 26, 2013)

Source page: https://510kreport.com/company/ormco