# Dentsply Intl.

- Location (FDA's records): York, PA
- FDA decisions: 291 (1976–2014): 291 510(k) clearances
- Names in FDA's records: Dentsply Intl. (279); Dentsply Intl., Inc. (12)
- Product codes: EBF (28), EIH (23), KLE (20), EMA (19), ELW (18), EBI (16), ELC (13), EBC (11), EFB (8), DYH (8), LBH (6), EJH (5)
- Predicates its devices cite: 127 (65 its own); citations of its devices by later devices: 247 (65 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dentsply International, Inc.: 6 (https://510kreport.com/company/dentsply-international)
- Friadent GmbH: 3 (https://510kreport.com/company/friadent)
- Degussa - Ney Dental, Inc.: 3 (https://510kreport.com/company/degussa-ney-dental)
- Heraeus Kulzer, Inc.: 2 (https://510kreport.com/company/heraeus-kulzer)
- Tulsa Dental Products, Ltd.: 2 (https://510kreport.com/company/tulsa-dental-products)
- 3M Company: 2 (https://510kreport.com/company/3m)
- Bisco, Inc.: 2 (https://510kreport.com/company/bisco)
- Degussa AG: 2 (https://510kreport.com/company/degussa)

## Firms that cite its devices most
- Dentsply International, Inc.: 27 (https://510kreport.com/company/dentsply-international)
- Espe Dental AG: 5 (https://510kreport.com/company/espe-dental)
- Vericom Co., Ltd.: 4 (https://510kreport.com/company/vericom)
- Dentsply Sirona: 4 (https://510kreport.com/company/dentsply-sirona)
- Discus Dental, Inc.: 4 (https://510kreport.com/company/discus-dental)
- Essential Dental Systems, Inc.: 4 (https://510kreport.com/company/essential-dental-systems)
- 3M Company: 3 (https://510kreport.com/company/3m)
- CAO Group, Inc.: 3 (https://510kreport.com/company/cao-group)

## Its most-cited devices
- K960548: AH Plus Root Canal Sealer (1996), cited by 11
- K873689: Cranioplastic, Acrylic Cranioplasty Material (1987), cited by 10
- K053167: Biopure Mtad Root Canal Cleanser (2005), cited by 9
- K982394: Prime & Bond NT Dual Cure Universal Dental Adhesive System (1998), cited by 8
- K083805: Ankylos C/X Dental Implant System (2009), cited by 8
- K973221: Composite 168 Restorative System (1998), cited by 5

## Recent decisions
- K140347: Ankylos C/X Implant System (Aug 20, 2014)
- K130862: Cavitron Prophy-Jet Air Polishing Prophylaxis System (Jul 23, 2013)
- K123615: Iris - High Strength Glass Ceramic (Feb 22, 2013)
- K103244: Qmix 2IN1 Endodontic Irrigating Solution (Feb 14, 2011)
- K093221: Pre-Cemented Orthodontic Bracket System Extension II (Oct 30, 2009)
- K083805: Ankylos C/X Dental Implant System (May 22, 2009)
- K082198: Durashield Plus (Oct 29, 2008)
- K072730: Friadent Cercon and Ankylos Cercon Balance Abutments (Mar 27, 2008)

Source page: https://510kreport.com/company/dentsply-intl