510(k) Report

FDA applicant

Dentsply International, Inc.

York, PA59 decisions2001–20160 recalls

FDA records 59 decisions for Dentsply International, Inc. (York, PA) from 2001 to 2016: 59 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and EJT (Alloy, Gold-Based Noble Metal). Since 2016 its 510(k)s took a median of 252 days from receipt to decision, against 202 for FDA’s reviews in the same codes and years. Its devices cite 98 predicates, 10 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dentsply International”.

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 International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

5in 2016

2007: 82008: 32009: 32010: 12011: 32012: 42013: 32014: 22015: 32016: 5
2007high 8 (2007) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dentsply International, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dentsply International, Inc.’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, Endosseous8decisions
  • EJTAlloy, Gold-Based Noble Metal5decisions
  • ELCScaler, Ultrasonic5decisions
  • EIHPowder, Porcelain4decisions
  • EBFMaterial, Tooth Shade, Resin4decisions
  • LYCBone Grafting Material, Synthetic3decisions

Also: KLE (3), DZE (2), LBH (2), KIF (2), NXC (2), EBG (2).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 252 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 202 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 98 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 82 times; 10 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.

  • K073075Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant SystemsDentsply International, Inc. · 200810cite it
  • K060837IN-Ovation CDentsply International · 20069cite it
  • K011009White Mta MaterialDentsply International · 20016cite it
  • K041372Smartlite PS Pen-Style Led Curing LightDentsply International · 20045cite it
  • K122424Isus Implant SuprastructuresDentsply International, Inc. · 20134cite it
  • K112152Cercon HTDentsply International, Inc. · 20113cite it

What has FDA decided for it lately?

  • K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
  • K160232Disposable Barrier Sleeves and CoversDentsply International, Inc. · 2016
  • K151439Atlantis IsusDentsply International, Inc. · 2016
  • K152247ATLANTIS CrownDentsply International, Inc. · 2016
  • K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc. · 2016
  • K151619Prime&Bond Elect Universal Dental AdhesiveDentsply International, Inc. · 2015
  • K150535Cavitron Touch Ultrasonic Scaling SystemDentsply International, Inc. · 2015
  • K142178Proroot Mta White, Proroot Mta GrayDentsply International, Inc. · 2015

All 36 as Dentsply International, Inc. →All 23 as Dentsply International →

Other applicant names beginning “Dentsply”

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

Dentsply Intl. 291Dentsply Sirona 88Dentsply Interntional 13Dentsply Midwest 1Dentsply Implant 1Dentsply Implants Manufacturing GmbH 1Dentsply Ceramco 1Dentsply Gendex 1