# Formlabs Ohio, Inc.

- Location (FDA's records): Millbury, OH
- FDA decisions: 4 (2022–2026): 4 510(k) clearances
- Product codes: MQC (2), EBG (1), EBI (1)
- 510(k) review time since 2016: median 132 days, against 132 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Keystone Industries: 2 (https://510kreport.com/company/keystone-industries)
- Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG: 1 (https://510kreport.com/company/bego-bremer-goldschlagerei-wilh-herbst)
- Mycone Dental Supply Co. Inc. (Dba Keystone Industries): 1 (https://510kreport.com/company/mycone-dental-supply-co-dba-keystone-industries)
- Dentsply Sirona: 1 (https://510kreport.com/company/dentsply-sirona)

## Its most-cited devices
- K222061: Dental LT Clear V2 Resin (2022), cited by 1

## Recent decisions
- K262300: Denture Base Resin V2 (Jul 8, 2026)
- K240538: Premium Teeth Resin (Jul 19, 2024)
- K232087: Dental LT Comfort Resin (Feb 16, 2024)
- K222061: Dental LT Clear V2 Resin (Nov 10, 2022)

Source page: https://510kreport.com/company/formlabs-ohio