510(k) Report

FDA applicant

Dentsply Sirona

York, PA88 decisions2016–20261 recall

FDA records 88 decisions for Dentsply Sirona (York, PA) from 2016 to 2026: 88 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 123 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 114 predicates, 37 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Dentsply Sirona, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Dentsply Sirona’s devices, and how often a recall has named them.

FDA decisions per year

12in 2025

2016: 72017: 102018: 82019: 92020: 112021: 52022: 62023: 42024: 82025: 122026 (partial year): 8
2016high 12 (2025) · low 4 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2016high 1 (2024) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Dentsply Sirona by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dentsply Sirona’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NHAAbutment, Implant, Dental, Endosseous23decisions
  • DZEImplant, Endosseous, Root-Form9decisions
  • EBIResin, Denture, Relining, Repairing, Rebasing6decisions
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories6decisions
  • EIHPowder, Porcelain5decisions
  • LLZSystem, Image Processing, Radiological3decisions

Also: NDP (3), OAS (3), QIH (3), NXC (3), EBF (2), PNN (2).

How long do its 510(k) reviews take?

Since 2016, its 82 510(k)s took a median of 123 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 150 days; 56 of its 82 were faster than that.

Whose devices does it build on?

Its devices cite 114 predicates; 37 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 55 times; 37 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K180044SIROLaser BlueDentsply Sirona · 20184cite it
  • K170500SIROLaser Advance+Dentsply Sirona · 20173cite it
  • K181520Sirona Dental CAD/CAM SystemDentsply Sirona · 20183cite it
  • K171122CEREC Ortho SoftwareDentsply Sirona · 20182cite it
  • K250081Atlantis® Abutments in TitaniumDentsply Sirona · 20252cite it
  • K190043Halley resinDentsply Sirona · 20192cite it

What has FDA decided for it lately?

  • K261935Surgical and Prosthetic TraysDentsply Sirona, Inc. · 2026
  • K262127DS Core CBCT AnatomyDentsply Sirona · 2026
  • K260785DS Core CBCT AnatomyDentsply Sirona · 2026
  • K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc. · 2026
  • K253565SureSmile SoftwareDentsply Sirona, Inc. · 2026
  • K251614Stainless Steel Surgical KitsDentsply Sirona, Inc. · 2026
  • K253959Primevision 3DDentsply Sirona · 2026
  • K253009DS Core DetectDentsply Sirona, Inc. · 2026

All 66 as Dentsply Sirona →All 22 as Dentsply Sirona, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K230199BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner…Nov 4, 2024Class II

Other applicant names beginning “Dentsply”

FDA records each applicant name separately; these may or may not be the same firm.

Dentsply Intl. 291Dentsply International, Inc. 59Dentsply Interntional 13Dentsply Midwest 1Dentsply Implant 1Dentsply Implants Manufacturing GmbH 1Dentsply Ceramco 1Dentsply Gendex 1