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

Des Plaines, IL, US

Dentsply Intl. appears in FDA device records in Des Plaines, IL. FDA records list 291 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
291
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 291

FDA records hold 291 510(k) clearances for Dentsply Intl. between 1976 and 2014. The busiest year on record is 1985, with 19. The most recent is 2014, with 1.

Clearances by year, as a table
510(k) clearance decisions for Dentsply Intl., by decision year
YearClearances
19763
19774
19786
19793
198013
19817
19828
198310
19846
198519
198613
198715
198811
19898
199014
19918
199212
19937
199411
19957
19968
199713
199812
19999
20006
20014
20026
200310
200415
20058
20063
20073
20083
20092
20111
20132
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K140347ANKYLOS C/X IMPLANT SYSTEMDZESubstantially Equivalent
K130862CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEMELCSubstantially Equivalent
K123615IRIS - HIGH STRENGTH GLASS CERAMICEIHSubstantially Equivalent
K103244QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTIONKJJSubstantially Equivalent
K093221PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION IIDYHSubstantially Equivalent
K083805ANKYLOS C/X DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K082198DURASHIELD PLUSLBHSubstantially Equivalent
K072730FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTSNHASubstantially Equivalent
K072989AXIS SYSTEMEFBSubstantially Equivalent
K073117DENTIN DESENSITIZER AGENTLBHSubstantially Equivalent
K070538XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVEKLESubstantially Equivalent
K070019CARRARA VOLUMIAEIHSubstantially Equivalent
K062828MOUTHGUARD AND ALIGNER MATERIALSMQCSubstantially Equivalent
K060836VISTADENT OC - VERSION 4LLZSubstantially Equivalent
K061427PRE-IMPRESSION CONDITIONING SOLUTIONELWSubstantially Equivalent
K053167BIOPURE MTAD ROOT CANAL CLEANSERKJJSubstantially Equivalent
K053010VISTADENT AT COMPLETE, MODEL 3.1LLZSubstantially Equivalent
K052334CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131ELCSubstantially Equivalent
K051707ECLIPSE BONDING AGENTKLESubstantially Equivalent
K051463XENO ADHESIVE WITH ACTIVATORKLESubstantially Equivalent
K051462MODIFICATION TO: CERCON BASEEIHSubstantially Equivalent
K050880DYRACT EXTRA RESTORATIVEEBFSubstantially Equivalent
K050750LC BRACKET ADHESIVE SYSTEMDYHSubstantially Equivalent
K043247DUCERA ALLCERAMEIHSubstantially Equivalent
K042905NEO-CLIP ORTHODONTIC BRACKET ACCESSORYNJMSubstantially Equivalent
K041272DYRACT CEM PLUS CEMENTEMASubstantially Equivalent
K042178ORTHODONTIC CERAMIC BRACKETSNJMSubstantially Equivalent
K041707CERCON CERAM EXPRESS CERAMIC SYSTEMEIHSubstantially Equivalent
K041141DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125EFBSubstantially Equivalent
K040906CALIBRA CEMENTEMASubstantially Equivalent
K040895INTEGRITY TEMPORARY CEMENTEMASubstantially Equivalent
K040375IDEAL 1 ORTHODONTIC BAND CEMENTDYHSubstantially Equivalent
K040635CARRARA INTERACTION CERAMIC SYSTEMEIHSubstantially Equivalent
K040421DUCERAGOLD PORCELAINSEIHSubstantially Equivalent
K040420DUCERAM PLUS CERAMIC SYSTEMEIHSubstantially Equivalent
K033703IDEAL 1 ORTHODONTIC BRACKET ADHESIVEDYHSubstantially Equivalent
K033667CARRARA PRESS SYSTEMEIHSubstantially Equivalent
K032361ENDOPURE ROOT CANAL CLEANSERKJJSubstantially Equivalent
K033553PFZ PORCELAIN SYSTEMEIHSubstantially Equivalent
K032904ACUCAM CONCEPT IV FWT, MODEL 110-0185G1EIASubstantially Equivalent
K024133CLS-2000 UNITFLESubstantially Equivalent
K032317ORION GX ALLOYEJTSubstantially Equivalent
K032316ORION E ALLOYEJTSubstantially Equivalent
K032892MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEMEBISubstantially Equivalent
K031932FLUORIDE VARNISHLBHSubstantially Equivalent
K031461CARRIER TIPSELCSubstantially Equivalent
K031145ESTYLUS ELECTRIC MOTOR SYSTEMEFBSubstantially Equivalent
K023776XENO III DENTAL ADHESIVEKLESubstantially Equivalent
K022796CERCON CERAM S PORCELAINEIHSubstantially Equivalent
K021805SEAL & PROTECT PROTECTIVE SEALANTLBHSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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