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

HAARLEM Noord-Holland, NL

CAVEX HOLLAND B.V. appears in FDA device records in HAARLEM Noord-Holland, NL. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. 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
26
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 26 510(k) clearances for Cavex Holland B.V. between 1998 and 2015. The busiest year on record is 1998, with 9. The most recent is 2015, with 1.

Clearances by year, as a table
510(k) clearance decisions for Cavex Holland B.V., by decision year
YearClearances
19989
20001
20014
20022
20031
20041
20052
20062
20071
20081
20141
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K151535Cavex Cream AlginateELWSubstantially Equivalent
K141092MARK3ELWSubstantially Equivalent
K073539PROVISA CEMEMBSubstantially Equivalent
K072245EMULATE ADVANCEDELWSubstantially Equivalent
K062400IMPRESSIX, COLORCHANGE ALGINATEELWSubstantially Equivalent
K061267SIMULATE, COLOR CHANGE ALGINATEELWSubstantially Equivalent
K052455IMPRESSIXELWSubstantially Equivalent
K051207CAVEX ORTHOTRACEELWSubstantially Equivalent
K042806QUADRANT UNIT-1-BONDKLESubstantially Equivalent
K032116TULIP COLORSWITCHELWSubstantially Equivalent
K023466TULIP ALGINATE IMPRESSION MATERIALELWSubstantially Equivalent
K020242EMULATE FAST SET AND EMULATE REGULAR SETELWSubstantially Equivalent
K013336XANTALGIN CRONOELWSubstantially Equivalent
K011452CAVEX STABISILELWSubstantially Equivalent
K011419CAVEX COLORCHANGEELWSubstantially Equivalent
K003791CAVEX TEMPORARY CEMENTEMASubstantially Equivalent
K000686KROM-ALGINATE AND ALGINATE PLUSELWSubstantially Equivalent
K984044QUADRANT POSTERIOR DENSEEBFSubstantially Equivalent
K984043QUADRANT TOTAL ETCHEBFSubstantially Equivalent
K984042QUADRANT CORE LCEBFSubstantially Equivalent
K984041QUADRANT UNIVERSAL LCEBFSubstantially Equivalent
K983751QUADRANT UNICHEMEBFSubstantially Equivalent
K983549QUADRANT ANTERIOR SHINEEBFSubstantially Equivalent
K983545QUADRANT UNIBONDKLESubstantially Equivalent
K981970ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXIELWSubstantially Equivalent
K980965SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIALELWSubstantially Equivalent

Registered establishments

FDA registered establishments for Cavex Holland B.V., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96145733008898734CAVEX HOLLAND B.V.FUSTWEG 5, HAARLEM Noord-Holland 2031CJ NL2026and 4 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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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