FDA.reportPublic FDA data

510(k) K022299

Device
TRILUX, Z-TONE, ACRY ROCK
Applicant
RUTHIBRAS IMP. EXP. COM. DE MATERIAIS ODONTOLOGICO
510(k) number
K022299
Product code
ELM  
Decision
Substantially Equivalent (SESE)
Decision date
2002-10-07
Date received
2002-07-16
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

Applicant Contact#

Contact
Kevin Walls
Address
13 Red Fox Ln. Littleton CO US 80127 80127

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases