# Dentsply International, Inc.

- Location (FDA's records): York, PA
- FDA decisions: 59 (2001–2016): 59 510(k) clearances
- Names in FDA's records: Dentsply International, Inc. (36); Dentsply International (23)
- Product codes: NHA (8), EJT (5), ELC (5), EIH (4), EBF (4), LYC (3), KLE (3), DZE (2), LBH (2), KIF (2), NXC (2), EBG (2)
- 510(k) review time since 2016: median 252 days, against 202 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 98 (10 its own); citations of its devices by later devices: 82 (10 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
- Dentsply Intl.: 27 (https://510kreport.com/company/dentsply-intl)
- Astra Tech, Inc.: 7 (https://510kreport.com/company/astra-tech)
- Nobel Biocare AB: 6 (https://510kreport.com/company/nobel-biocare)
- Friadent GmbH: 6 (https://510kreport.com/company/friadent)
- Degussa AG: 5 (https://510kreport.com/company/degussa)
- Coors Biomedical Co.: 4 (https://510kreport.com/company/coors-biomedical)
- Ceramed Corp.: 3 (https://510kreport.com/company/ceramed)
- Dentsply Implants Manufacturing GmbH: 2 (https://510kreport.com/company/dentsply-implants-manufacturing)

## Firms that cite its devices most
- Dentsply Sirona: 7 (https://510kreport.com/company/dentsply-sirona)
- Dentsply Intl.: 6 (https://510kreport.com/company/dentsply-intl)
- Dentsply Interntional: 4 (https://510kreport.com/company/dentsply-interntional)
- Terrats Medical SL: 2 (https://510kreport.com/company/terrats-medical)
- Cdb Corporation: 2 (https://510kreport.com/company/cdb)
- Vericom Co., Ltd.: 2 (https://510kreport.com/company/vericom)
- Innovative Bioceramix, Inc.: 2 (https://510kreport.com/company/innovative-bioceramix)
- Ivoclar Vivadent, Inc.: 2 (https://510kreport.com/company/ivoclar-vivadent)

## Its most-cited devices
- K073075: Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems (2008), cited by 10
- K060837: IN-Ovation C (2006), cited by 9
- K011009: White Mta Material (2001), cited by 6
- K041372: Smartlite PS Pen-Style Led Curing Light (2004), cited by 5
- K122424: Isus Implant Suprastructures (2013), cited by 4
- K112152: Cercon HT (2011), cited by 3

## Recent decisions
- K160207: ATLANTIS ISUS Implant Suprastructures (Sep 21, 2016)
- K160232: Disposable Barrier Sleeves and Covers (Jun 7, 2016)
- K151439: Atlantis Isus (Feb 19, 2016)
- K152247: ATLANTIS Crown (Jan 29, 2016)
- K151039: ATLANTIS Abutment for NobelActive 3.0 (Jan 14, 2016)
- K151619: Prime&Bond Elect Universal Dental Adhesive (Oct 30, 2015)
- K150535: Cavitron Touch Ultrasonic Scaling System (Jun 16, 2015)
- K142178: Proroot Mta White, Proroot Mta Gray (Feb 26, 2015)

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