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510(k) K033628

Device
ARTIC
Applicant
HERAEUS KULZER, INC.
510(k) number
K033628
Product code
ELM  
Decision
Substantially Equivalent (SESE)
Decision date
2004-01-16
Date received
2003-11-19
Regulation
872.3590
Classification name
Denture, Plastic, Teeth
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHERYL V ZIMMERMAN
Address
4315 S Lafayette Blvd. South Bend IN US 46614 46614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ELM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K132984SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL SIvoclar Vivadent, Inc.2014-01-14
K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.2013-03-01
K122925NEW STETIC ARTIFICIAL TEETHNew Stetic2013-02-12
K122852PHYSIOSTAR NFCCandulor USA, Inc.2012-12-06
K121749VERACIAShofu Dental Corporation2012-09-07
K120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbH2012-05-21
K120736SR PHONARES IIIvoclar Vivadent, AG2012-05-14
K113426VERACIA SAShofu Dental Corporation2012-02-08
K101064BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN PBredent GmbH & Co. KG2010-09-14
K101029KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETHHuge Dental Material Co., Ltd.2010-08-16
K093331SR PHONARES NHCIvoclar Vivadent, Inc.2010-01-28
K092231GEBDI TRIBOS 501Gebdi Dental-Products GmbH2009-11-24
K070591REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETHUnion Dental S.A./Unidesa.Odi2007-05-11
K060720CURATIVE DENTAL ACRYLIC TEETHCurative, LLC2006-08-25
K061337WIEDENT ESTETICXpdent Corp2006-06-07

Legacy Summary#

summary

FDA Review#

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