FDA.report

DELTAMED GMBH

Matched from indexed company URL: DeltaMed GmbH

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30027895263002789526DELTAMED GMBH1N2026-01-01RAIFFEISENSTR. 8a FRIEDBERG Hesse DE D-61169

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
164811029474182K993659RENAMEL PACKEBF2000-01-18
164812045748907K980800LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIALEBF1998-11-09
164811481504884K980799HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIALEBG1998-10-28
164811138946697K980298FLOWABLE HYBRIDEBD1998-03-09
164811216327773K974494RENAMEL FLOWABLE COMPOSITEEBD1998-02-10
164811401233868K921820RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATIONEBF1992-06-16
164811763965165K894477INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEMEMA1990-01-10
164811876916298K873356INSURE PORCELAIN VENEER BONDING SYSTEMEMA1987-12-29
164811426083801K862912RENAMELIZE POLISHING PASTEEJR1986-08-12
164811974423999K854755RENAMEL ESTHETIC RESTORATIVE SYSTEMEBF1986-03-13
164811195788022K2437203Delta UNlimitedEBF2024-12-18
164811770094624K240714Insure® Universal; Insure® Universal AutomixEMA2024-07-24
164811195115784K230341ACRIFIXEBI2023-04-06
164811605058519K222435Renamel® Microhybrid ;Renamel® Flowable MicrohybridEBF2022-10-11
164811487031068K2125413Delta Denture Base - 3Delta Denture Bond - 3Delta Denture FixEBI2022-01-10
164811322517816K2118043Delta CrownEBF2021-12-06
164811247882162K211259Renamel BulkfillEBF2021-06-24
164811093177318K200039P pro Crown & BridgeEBG2020-07-31
164811401320358K172707Renamel MicrofillEBF2017-12-05
164811244552126K163480Renamel NANO +plusEBF2017-02-24
164811003800247K102776EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEMEBG2011-02-18
164811897026672K092730COSMEDENT BRUSHABLE COMPOSITEEBF2009-11-20
164811314719726K070583NANO COMPOSITEEBF2007-04-16
164811379121155K052501MULTIPLE RESIN TOOTH BONDING AGENTKLE2005-10-21
164811052891778K042823COSMEDENT PIT & FISSURE SEALANTEBC2004-12-01
164811522577897K040994COSMEDENT CORE PASTEEBF2004-06-03
164811569060232K030832PRIMOSPLINT SYSTEMMQC2003-09-17
164811025064013K011239GINDA GUARDEBD2002-02-14
164811574870014
164811654426222
164811806115904
164811858942040
164811920206285

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
EBF132024-12-18
EMA32024-07-24
EBG32020-07-31
EBD32002-02-14
EBI22023-04-06
KLE12005-10-21
EBC12004-12-01
MQC12003-09-17
EJR11986-08-12

PMN

GUDID

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