# Dentsply Interntional

- Location (FDA's records): York, PA
- FDA decisions: 13 (2007–2009): 13 510(k) clearances
- Product codes: NJM (2), KIF (2), LYC (2), EMA (1), EKX (1), ELC (1), EBG (1), NXC (1), DYW (1), DYH (1)
- Predicates its devices cite: 23 (4 its own); citations of its devices by later devices: 18 (4 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 International, Inc.: 4 (https://510kreport.com/company/dentsply-international)
- Ceramed Corp.: 4 (https://510kreport.com/company/ceramed)
- Dentsply Intl.: 2 (https://510kreport.com/company/dentsply-intl)
- Ceramed Dental, LLC: 2 (https://510kreport.com/company/ceramed-dental)
- Gac Intl., Inc.: 2 (https://510kreport.com/company/gac-intl)
- 3M Espe AG Dental Products: 1 (https://510kreport.com/company/3m-espe-ag-dental-products)
- Sybron Dental Specialties, Inc.: 1 (https://510kreport.com/company/sybron-dental-specialties)
- Nsk Nakanishi, Inc.: 1 (https://510kreport.com/company/nsk-nakanishi)

## Firms that cite its devices most
- Tomy, Inc.: 2 (https://510kreport.com/company/tomy)
- Meta Biomed Co., Ltd.: 2 (https://510kreport.com/company/meta-biomed)
- Angelus Industria DE Productos Odontologicos: 2 (https://510kreport.com/company/angelus-industria-de-productos-odontologicos)
- Paxmed International: 1 (https://510kreport.com/company/paxmed-international)
- 3M Unitek: 1 (https://510kreport.com/company/3m-unitek)
- Saeshin Precision Co., Ltd.: 1 (https://510kreport.com/company/saeshin-precision)
- Ortho Specialties: 1 (https://510kreport.com/company/ortho-specialties)
- Dentsply International, Inc.: 1 (https://510kreport.com/company/dentsply-international)

## Its most-cited devices
- K082974: Mystique MB Ceramic Brackets (2008), cited by 4
- K080203: Mta Root Canal Sealer (2008), cited by 3
- K092614: X-Smart Easy (2009), cited by 3
- K073173: Self-Adhesive Resin Cement (2008), cited by 2
- K073218: Mta Advanced Material (2008), cited by 2
- K092030: Elation MB Metal Reinforced Plastic Bracket (2009), cited by 2

## Recent decisions
- K092614: X-Smart Easy (Dec 2, 2009)
- K092030: Elation MB Metal Reinforced Plastic Bracket (Jul 24, 2009)
- K090454: Allure MB Ceramic Brackets (Mar 20, 2009)
- K082973: Ster-Mate Sterile Lavage Kit (Jan 29, 2009)
- K082974: Mystique MB Ceramic Brackets (Nov 7, 2008)
- K081291: Pre-Cemented Orthodontic Bracket System Extension (May 22, 2008)
- K080311: Modified Temprx Esthetic Provisional System (Apr 18, 2008)
- K080246: Composite Aligner Button (Apr 11, 2008)

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