# Keystone Dental, Inc.

- Location (FDA's records): Burlington, MA
- FDA decisions: 8 (2007–2024): 8 510(k) clearances
- Names in FDA's records: Keystone Dental, Inc. (7); Keystone Dental (1)
- Product codes: DZE (5), NHA (2), LLZ (1)
- 510(k) review time since 2016: median 91 days, against 226 for FDA's reviews in the same codes and years (4 of 4 faster)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 8 (3 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
- Nobel Biocare AB: 3 (https://510kreport.com/company/nobel-biocare)
- Southern Implants (Pty), Ltd.: 2 (https://510kreport.com/company/southern-implants)
- Institut Straumann AG: 2 (https://510kreport.com/company/institut-straumann)
- Paltop Advanced Dental Solutions, Ltd.: 1 (https://510kreport.com/company/paltop-advanced-dental-solutions)
- Lifecore Biomedical, Inc.: 1 (https://510kreport.com/company/lifecore-biomedical)
- Implant Innovations, Inc.: 1 (https://510kreport.com/company/implant-innovations)

## Firms that cite its devices most
- Biodenta Swiss AG: 2 (https://510kreport.com/company/biodenta-swiss)
- Dentsply International, Inc.: 1 (https://510kreport.com/company/dentsply-international)
- Astra Tech, Inc.: 1 (https://510kreport.com/company/astra-tech)
- Orthofundamentals, LLC: 1 (https://510kreport.com/company/orthofundamentals)

## Its most-cited devices
- K101545: Genesis Implant System (2010), cited by 7
- K223814: Genesis ACTIVE Implant System (2023), cited by 1

## Recent decisions
- K240966: Prima Plus Conical Implant System (Jul 9, 2024)
- K223814: Genesis ACTIVE Implant System (May 25, 2023)
- K221381: KDG Abutments (Aug 10, 2022)
- K201334: Keystone Dental XL Dental Implant System (Aug 18, 2020)
- K101545: Genesis Implant System (Oct 28, 2010)
- K090397: Xpi Angled Abutments (Jun 5, 2009)
- K071070: Olympus Dental Implant System (Oct 23, 2007)
- K071599: Easyguide (Jul 11, 2007)

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