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

Ayer, MA, US

Dmg USA, Inc. appears in FDA device records in Ayer, MA. FDA records list 28 510(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
28
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 28 510(k) clearances for Dmg USA, Inc. between 2000 and 2018. The busiest year on record is 2001, with 6. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Dmg USA, Inc., by decision year
YearClearances
20003
20016
20022
20031
20042
20061
20071
20083
20105
20111
20141
20161
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K171772Ecosite Bulk FillEBFSubstantially Equivalent
K160443TempoCem ClearEMASubstantially Equivalent
K130580RETRACTION PASTEMVLSubstantially Equivalent
K110759TEMPOCEMEMBSubstantially Equivalent
K102603SA FLOWABLE ADHESIVEEBFSubstantially Equivalent
K101710LUXATEMP ULTRA /STAREBGSubstantially Equivalent
K100062INFILTRATION KITEBCSubstantially Equivalent
K093338SELF ADHESIVE COMPOSITE LUTING CEMENTEMASubstantially Equivalent
K093587DENTAL MERCURYELYSubstantially Equivalent
K081493INFILTRATION KITEBCSubstantially Equivalent
K080480NANOCOMPOSITE RESTORATIVE KITEBFSubstantially Equivalent
K080479DENTAL CERAMICEIHSubstantially Equivalent
K063444TOTAL ETCH BONDING AGENTKLESubstantially Equivalent
K052800PROVISIONAL INLAY/ONLAY KITEBGSubstantially Equivalent
K041960COMPOSITE/COMPOMER REPAIR KITKLESubstantially Equivalent
K033227LUXAFORM PLUSEBGSubstantially Equivalent
K023649VITIQUE SYSTEMEMASubstantially Equivalent
K013674LUXATEMP/LUXATEMP SOLAR/INSTATEMPEBGSubstantially Equivalent
K013571MAGICFILEBFSubstantially Equivalent
K013237STATUSBLUEELWSubstantially Equivalent
K013236LUXABITEELWSubstantially Equivalent
K013179LUXAGLAZEEBDSubstantially Equivalent
K012316PERMACEM / PERMACEM DUALEMASubstantially Equivalent
K012307LUXACORE/LUXACORE DUALEBFSubstantially Equivalent
K011211FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOWEBFSubstantially Equivalent
K002086PRIMAFLOWEBFSubstantially Equivalent
K000878HONIGUMELWSubstantially Equivalent
K000951LUXAFORMEBGSubstantially 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

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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What MDM checks, and what it does not

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