510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Dentsply Sirona Inc

York, PA, US

DENTSPLY SIRONA INC appears in FDA device records in York, PA. FDA records list 86 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
86
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Dentsply Sirona Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Dentsply Worldwide Headqrtrecall

510(k) clearance history

Showing 50 of 86

FDA records hold 86 510(k) clearances for Dentsply Sirona Inc between 2016 and 2026. The busiest year on record is 2025, with 12. The most recent is 2026, with 6.

Clearances by year, as a table
510(k) clearance decisions for Dentsply Sirona Inc, by decision year
YearClearances
20167
201710
20188
20199
202011
20215
20226
20234
20248
202512
20266
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260785DS Core CBCT AnatomyQIHSubstantially Equivalent
K260722SureSmile Aligner (ASSY500020)NXCSubstantially Equivalent
K253565SureSmile SoftwarePNNSubstantially Equivalent
K251614Stainless Steel Surgical KitsKCTSubstantially Equivalent
K253959Primevision 3DOASSubstantially Equivalent
K253009DS Core DetectMYNSubstantially Equivalent
K252343Atlantis® Abutments in TitaniumNHASubstantially Equivalent
K252248CEREC Tessera Abutment SystemNHASubstantially Equivalent
K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsNHASubstantially Equivalent
K250771Primescan 2NTKSubstantially Equivalent
K251811Motor and Apex Module (MaAM)EBWSubstantially Equivalent
K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection SystemDZESubstantially Equivalent
K250755DS Core DiagnosisQIHSubstantially Equivalent
K251297MIS LYNX Conical Connection Implant SystemDZESubstantially Equivalent
K251300Plastic Surgical KitsKCTSubstantially Equivalent
K250295Dentsply Sirona Titanium Bases systemNHASubstantially Equivalent
K250081Atlantis® Abutments in TitaniumNHASubstantially Equivalent
K243546AH Plus Endodontic SealerKIFSubstantially Equivalent
K243336Lucitone Digital Print Denture™ SystemEBISubstantially Equivalent
K241692MIS LYNX Conical Connection Implant SystemDZESubstantially Equivalent
K242462CEREC Cercon 4D CAD/CAM BlocksEIHSubstantially Equivalent
K241557Cercon® yo MLEIHSubstantially Equivalent
K233865X-Smart Pro; X-Smart Pro+EKXSubstantially Equivalent
K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemNHASubstantially Equivalent
K240888Calibra Abutment Resin CementEMASubstantially Equivalent
K231144WashtraysKCTSubstantially Equivalent
K231578Lucitone Digital Print Denture SystemEBISubstantially Equivalent
K230199Byte Aligner SystemNXCSubstantially Equivalent
K223756SimPro™ Now, GentleCath™ HydrophilicEZDSubstantially Equivalent
K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemNHASubstantially Equivalent
K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDZESubstantially Equivalent
K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)DZESubstantially Equivalent
K220791Surgical and Prosthetic TraysKCTSubstantially Equivalent
K213432MIS Angulated multi-unit abutmentsNHASubstantially Equivalent
K212281Surgical TraysKCTSubstantially Equivalent
K211212LoFric ElleEZDSubstantially Equivalent
K213449DS Implants abutments provided with the EV connectionNHASubstantially Equivalent
K210610PrimeTaper EV Dental ImplantDZESubstantially Equivalent
K211225MIS Ti-base abutmentNHASubstantially Equivalent
K210886MIS Lance+ Conical Connection Dental Implant SystemDZESubstantially Equivalent
K202629Dentsply Sirona Universal Spray GlazesEIHSubstantially Equivalent
K200102MIS Dental Implant SystemDZESubstantially Equivalent
K193405Simplant Digital GuideNDPSubstantially Equivalent
K200191Sirona Dental CAD/CAM System with InLab SoftwarePNPSubstantially Equivalent
K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareNHASubstantially Equivalent
K191152MIS Ti-base AbutmentNHASubstantially Equivalent
K201140AxeosOASSubstantially Equivalent
K193078MIS CONNECT Conical Connection SystemNHASubstantially Equivalent
K193529ATLANTIS Abutment for MIS Conical Connection ImplantsNHASubstantially Equivalent
K193064Atlantis suprastructuresNHASubstantially Equivalent

Registered establishments

FDA registered establishments for Dentsply Sirona Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30048841503004884150DENTSPLY SIRONA INC221 W Philadelphia St Ste 60w, York, PA 17401 US2026and 24 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1234-2009Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model numbers (SKU): C106KL0050A20 (12 posts) and C117K00000020 (4 posts), Swiss Made, Manufactured for DENTSPLY Maillefer, Johnson City, TN 37604The product is manufactured with a left-hand thread instead of a right hand thread. This error could cause tooth breakage if the posts were removed without knowing that the threads were reversed.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain