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

BENSHEIM Hesse, DE

SIRONA DENTAL SYSTEMS GMBH appears in FDA device records in BENSHEIM Hesse, DE. FDA records list 42 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
42
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 42 510(k) clearances for Sirona Dental Systems GmbH between 1998 and 2016. The busiest year on record is 2006, with 5. The most recent is 2016, with 1.

Clearances by year, as a table
510(k) clearance decisions for Sirona Dental Systems GmbH, by decision year
YearClearances
19982
19992
20002
20013
20034
20042
20052
20065
20084
20091
20101
20112
20121
20135
20141
20154
20161
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K160099CEREC SpeedGlazeEIHSubstantially Equivalent
K151045TENEO Dental Treatment Unit and AccessoriesEIASubstantially Equivalent
K150909INTEGO Family and AccesoriesEIASubstantially Equivalent
K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SprayEGSSubstantially Equivalent
K150217ORTHOPHOS SLOASSubstantially Equivalent
K131319T1/T2/T3 TURBINE FAMILYEFBSubstantially Equivalent
K132773SIDEXIS 4LLZSubstantially Equivalent
K123664INCORIS ZIEIHSubstantially Equivalent
K123952CEREC BLOCS C INEIHSubstantially Equivalent
K123070GALILEOS FAMILYOASSubstantially Equivalent
K123545INCORIS TZIEIHSubstantially Equivalent
K111421SIRONA DENTAL CAD/CAM SYSTEMNHASubstantially Equivalent
K103711ORTHOPHOS XG 3D / CEPHOASSubstantially Equivalent
K103753SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASERGEXSubstantially Equivalent
K100152SIRONA CAD/CAM SYSTEMNHASubstantially Equivalent
K092660SIROLASER ADVANCEGEXSubstantially Equivalent
K083344HELIODENT PLUSEHDSubstantially Equivalent
K081903XIOS PLUS WALL-MODULEMUHSubstantially Equivalent
K080882CEREC OPTI SPRAYELWSubstantially Equivalent
K072107PERIOSCAN, MODEL: D 3496ELCSubstantially Equivalent
K062509INCORIS ZIEIHSubstantially Equivalent
K062506INCORIS ALEIHSubstantially Equivalent
K060892GALILEOSMUHSubstantially Equivalent
K052515SIROENDOEKXSubstantially Equivalent
K053161SIROLASERGEXSubstantially Equivalent
K051661IMPLANT HANDPIECESEKXSubstantially Equivalent
K050354PERIOSCAN ULTRASONIC SCALERELCSubstantially Equivalent
K033812SIROAIR L AIR SCALEREFBSubstantially Equivalent
K033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERKOJSubstantially Equivalent
K033640SIROSON L AND SIROSONIC L ULTRASONIC SCALERSELCSubstantially Equivalent
K032543SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIESEIASubstantially Equivalent
K033073ORTHOPHOS XG DS/CEPHEHDSubstantially Equivalent
K031584SIROTORQUE LEBWSubstantially Equivalent
K013659MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEMMUHSubstantially Equivalent
K013650ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CDMUHSubstantially Equivalent
K012517CEREC3 VITABLOCKSELWSubstantially Equivalent
K000672HELIODENT VARIOEHDSubstantially Equivalent
K994172CEREC 3ELWSubstantially Equivalent
K992644SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEMMUHSubstantially Equivalent
K990528ORTHOPHOS 3/3 CEPH/3 DSMUHSubstantially Equivalent
K983242SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIESEIASubstantially Equivalent
K983057ORTHOPHOS 5/PLUS/CDMUHSubstantially Equivalent

Registered establishments

FDA registered establishments for Sirona Dental Systems GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96149773003719498SIRONA DENTAL SYSTEMS GMBHFABRIKSTRASSE 31, BENSHEIM Hesse D-64625 DE2026and 26 more, listed in full below
96818513002807009Sirona Dental Systems GmbHFABRIKSTRASSE 31, Bensheim Hesse 64625 DE2026and 1 more, listed in full below

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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