# Dentsply Sirona

- Location (FDA's records): York, PA
- FDA decisions: 88 (2016–2026): 88 510(k) clearances
- Names in FDA's records: Dentsply Sirona (66); Dentsply Sirona, Inc. (22)
- Product codes: NHA (23), DZE (9), EBI (6), KCT (6), EIH (5), LLZ (3), NDP (3), OAS (3), QIH (3), NXC (3), EBF (2), PNN (2)
- 510(k) review time since 2016: median 123 days, against 150 for FDA's reviews in the same codes and years (56 of 82 faster)
- Predicates its devices cite: 114 (37 its own); citations of its devices by later devices: 55 (37 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
- Sirona Dental Systems GmbH: 11 (https://510kreport.com/company/sirona-dental-systems)
- Dentsply International, Inc.: 7 (https://510kreport.com/company/dentsply-international)
- Astra Tech, Inc.: 6 (https://510kreport.com/company/astra-tech)
- Mis Implants Technologies, Ltd.: 5 (https://510kreport.com/company/mis-implants-technologies)
- Materialise Dental NV: 4 (https://510kreport.com/company/materialise-dental)
- Dentsply Intl.: 4 (https://510kreport.com/company/dentsply-intl)
- Ivoclar Vivadent, Inc.: 3 (https://510kreport.com/company/ivoclar-vivadent)
- Mis - Implant Technologies, Ltd.: 3 (https://510kreport.com/company/mis-implant-technologies)

## Firms that cite its devices most
- Nakanishi, Inc.: 2 (https://510kreport.com/company/nakanishi)
- Fotona D.O.O.: 2 (https://510kreport.com/company/fotona-doo)
- Guilin Woodpecker Medical Instrument Co., Ltd.: 2 (https://510kreport.com/company/guilin-woodpecker-medical-instrument)
- Cochlear: 1 (https://510kreport.com/company/cochlear)
- Kuraray Noritake Dental, Inc.: 1 (https://510kreport.com/company/kuraray-noritake-dental)
- Medency S.R.L.: 1 (https://510kreport.com/company/medency)
- Ray Co., Ltd.: 1 (https://510kreport.com/company/ray)
- Laon Medi, Inc.: 1 (https://510kreport.com/company/laon-medi)

## Its most-cited devices
- K180044: SIROLaser Blue (2018), cited by 4
- K170500: SIROLaser Advance+ (2017), cited by 3
- K181520: Sirona Dental CAD/CAM System (2018), cited by 3
- K171122: CEREC Ortho Software (2018), cited by 2
- K250081: Atlantis® Abutments in Titanium (2025), cited by 2
- K190043: Halley resin (2019), cited by 2

## Recent decisions
- K261935: Surgical and Prosthetic Trays (Sep 4, 2026)
- K262127: DS Core CBCT Anatomy (Aug 21, 2026)
- K260785: DS Core CBCT Anatomy (Apr 23, 2026)
- K260722: SureSmile Aligner (ASSY500020) (Apr 15, 2026)
- K253565: SureSmile Software (Mar 4, 2026)
- K251614: Stainless Steel Surgical Kits (Feb 6, 2026)
- K253959: Primevision 3D (Feb 5, 2026)
- K253009: DS Core Detect (Jan 7, 2026)

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