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

Amherst, NY, US

Ivoclar North America, Inc. appears in FDA device records in Amherst, NY. FDA records list 131 510(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
131
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 131

FDA records hold 131 510(k) clearances for Ivoclar North America, Inc. between 1989 and 2001. The busiest year on record is 1990, with 40. The most recent is 2001, with 10.

Clearances by year, as a table
510(k) clearance decisions for Ivoclar North America, Inc., by decision year
YearClearances
19891
199040
199116
19929
199310
19942
19958
19964
19979
19984
19999
20009
200110
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K012174ERIS LAYERING MATERIALSEIHSubstantially Equivalent
K011491HELIOSEAL CLEAR CHROMAEBCSubstantially Equivalent
K011492IN TEN-SEBFSubstantially Equivalent
K011490MODIFICATION TO EXCITEKLESubstantially Equivalent
K011023D.SIGN 96EJTSubstantially Equivalent
K011022BIOUNIVERSAL PDFEJTSubstantially Equivalent
K010381D.SIGN 30EJHSubstantially Equivalent
K010250TETRIC CERAM HBEBFSubstantially Equivalent
K003293EXCITE DSCKLESubstantially Equivalent
K003407SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)EMASubstantially Equivalent
K003635DW 276 #3EJTSubstantially Equivalent
K003634DW 272 #1EJTSubstantially Equivalent
K003633DW 277 #4EJTSubstantially Equivalent
K003632DW 273 #1EJSSubstantially Equivalent
K003377FERMIT N PLUSEBGSubstantially Equivalent
K003374FERMIT PLUSEBGSubstantially Equivalent
K003373PROCAD ADD-ONEIHSubstantially Equivalent
K002872R&D PROJECT DW271#11AEJTSubstantially Equivalent
K001469R&D PROJECT DW269#25EJSSubstantially Equivalent
K993783TETRIC FLOWEBFSubstantially Equivalent
K990817IPS D.SIGN PORCELAINEIHSubstantially Equivalent
K990534EXCITEKLESubstantially Equivalent
K990315MONOPAQUEEBFSubstantially Equivalent
K990235D-SIGN VI (R&D PROJECT DW266#9)EJHSubstantially Equivalent
K990182D-SIGN V (R&D PROJECT DW267#17)EJHSubstantially Equivalent
K990078D-SIGN IV (R&D PROJECT DW265#37)EJSSubstantially Equivalent
K990077D-SIGN III (R&D PROJECT DW264#7)EJSSubstantially Equivalent
K984451D-SIGN I (R&D PROJECT DW263 #24)EJSSubstantially Equivalent
K982616IPS EMPRESS 2EIHSubstantially Equivalent
K981335ARISTON PHC LINEREMASubstantially Equivalent
K980922PROTEC CEM.EMASubstantially Equivalent
K974577COMPOGLASS FLOWEBFSubstantially Equivalent
K973397SYNTAC SPRINTEMASubstantially Equivalent
K972648SONICSYS INLAYEIHSubstantially Equivalent
K972875COSMOPOSTELRSubstantially Equivalent
K972827IPS EMPRESS COSMO INGOTEIHSubstantially Equivalent
K971513COMPOGLASS FEBFSubstantially Equivalent
K971372VARIOLINK IIEBFSubstantially Equivalent
K970963TARGIS ALLOY #7EJTSubstantially Equivalent
K964285TETRIC CERAMEBFSubstantially Equivalent
K964772AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)EJTSubstantially Equivalent
K962878TARGIS SYSTEMEBFSubstantially Equivalent
K962456SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETHELMSubstantially Equivalent
K962297VIVAGLASS CEMEMASubstantially Equivalent
K961910VIVAGLASS FILEMASubstantially Equivalent
K954837DW260 19EJTSubstantially Equivalent
K951836COMPOLGLASS COMPOGLASS SCAEBFSubstantially Equivalent
K951298MAXIGOLD KFEJTSubstantially Equivalent
K951297HARMONY LINE KFEJTSubstantially Equivalent
K950517HARMONY LINE PFEJTSubstantially 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