# Keystone Industries

- Location (FDA's records): Gibbstown, NJ
- FDA decisions: 3 (2019–2025): 3 510(k) clearances
- Product codes: EBI (2), MQC (1)
- 510(k) review time since 2016: median 188 days, against 90 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 13 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Envisiontec GmbH: 1 (https://510kreport.com/company/envisiontec)
- Cosmetic Dental Materials, Inc.: 1 (https://510kreport.com/company/cosmetic-dental-materials)

## Firms that cite its devices most
- Prismatik Dentalcraft, Inc.: 2 (https://510kreport.com/company/prismatik-dentalcraft)
- Pro3Dure Medical GmbH: 2 (https://510kreport.com/company/pro3dure-medical)
- Formlabs Ohio, Inc.: 2 (https://510kreport.com/company/formlabs-ohio)
- LuxCreo, Inc.: 1 (https://510kreport.com/company/luxcreo)
- Detax GmbH & Co. KG: 1 (https://510kreport.com/company/detax)
- Envisiontec GmbH: 1 (https://510kreport.com/company/envisiontec)
- Whip-Mix Corp.: 1 (https://510kreport.com/company/whip-mix)
- Mycone Dental Supply Co. Inc. (Dba Keystone Industries): 1 (https://510kreport.com/company/mycone-dental-supply-co-dba-keystone-industries)

## Its most-cited devices
- K183598: KeyPrint KeySplint Soft (2019), cited by 11
- K241089: KeyPrint KeyDenture Base (2024), cited by 1
- K250489: FP3D (2025), cited by 1

## Recent decisions
- K250489: FP3D (May 20, 2025)
- K241089: KeyPrint KeyDenture Base (Oct 24, 2024)
- K183598: KeyPrint KeySplint Soft (Nov 15, 2019)

Source page: https://510kreport.com/company/keystone-industries