FDA.report

510(k) K992854

Device
ARTIFICIAL TEETH (ACRYLIC TEETH)
Applicant
MASTERDENT LTDA.
510(k) number
K992854
Product code
ELM  
Decision
Substantially Equivalent (SESE)
Decision date
2000-02-07
Date received
1999-08-24
Regulation
872.3590
Classification name
Denture, Plastic, Teeth
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
JUAN FERNANDO SALAZAR
Address
7150 NW 72 Ave. Miami FL US 33166 33166

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Related GUDID Devices

Primary DIBrandCompanyPublished
D873SNANTUPP264A2621STARTONEMASTERDENT LTDA2021-06-25
D873SNPOSLOW32MA3661STARTONEMASTERDENT LTDA2021-06-25
D873SNPOSLOW32MA35651STARTONEMASTERDENT LTDA2021-06-25
D873SNPOSLOW32LA3661STARTONEMASTERDENT LTDA2021-06-25
D873SNPOSLOW32LA35651STARTONEMASTERDENT LTDA2021-06-25
D873SNPOSLOW32LA2621STARTONEMASTERDENT LTDA2021-06-25
D873SNPOSLOW30MA3661STARTONEMASTERDENT LTDA2021-06-25
D873SNPOSLOW30MA35651STARTONEMASTERDENT LTDA2021-06-25
D873SNPOSLOW30MA2621STARTONEMASTERDENT LTDA2021-06-25
D873SNPOLOW32MA2621STARTONEMASTERDENT LTDA2021-06-25
D873SNANTUPP266A3661STARTONEMASTERDENT LTDA2021-06-25
D873SNANTUPP266A35651STARTONEMASTERDENT LTDA2021-06-25
D873SNANTUPP266A2621STARTONEMASTERDENT LTDA2021-06-25
D873SNANTUPP264A3661STARTONEMASTERDENT LTDA2021-06-25
D873SNANTUPP264A35651STARTONEMASTERDENT LTDA2021-06-25
D873SNPOSLOW34LA2621STARTONEMASTERDENT LTDA2021-06-25
D873SNANTUPP263A3661STARTONEMASTERDENT LTDA2021-06-25
D873SNANTUPP263A35651STARTONEMASTERDENT LTDA2021-06-25
D873SNANTUPP263A2621STARTONEMASTERDENT LTDA2021-06-25
D873SNANTLOW266A3661STARTONEMASTERDENT LTDA2021-06-25
D873SNANTLOW266A35651STARTONEMASTERDENT LTDA2021-06-25
D873SNANTLOW266A2621STARTONEMASTERDENT LTDA2021-06-25
D873SNANTLOW264A3661STARTONEMASTERDENT LTDA2021-06-25
D873SNANTLOW264A35651STARTONEMASTERDENT LTDA2021-06-25
D873SNANTLOW264A2621STARTONEMASTERDENT LTDA2021-06-25
D873SNANTLOW263A3661STARTONEMASTERDENT LTDA2021-06-25
D873SNANTLOW263A35651STARTONEMASTERDENT LTDA2021-06-25
D873SNANTLOW263A2621STARTONEMASTERDENT LTDA2021-06-25
D873ANPOSUPP32MA35651STARTONEMASTERDENT LTDA2021-06-25
D873SNPOSLOW34LA35651STARTONEMASTERDENT LTDA2021-06-25

Other 510(k) Records For Product Code ELM  

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

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FDA Review

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