FDA.reportPublic FDA data

Vitique

Primary DI
EDMG2130821
Brand
Vitique
Company
DMG Chemisch-Pharmazeutische Fabrik GmbH
Model
213082
Catalog number
213082
Device description
Accessory kit for definitive cementation of veneers. Veneer cementation with added value. Content: 1 bottle @ 3 ml Silane Adhesive, 1 bottle @ 3 ml Silane Activator, 1 bottle @ 5 ml Bond, 1 syringe @2 ml Etching Gel, accessories.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBCSealant, Pit And Fissure, And Conditioner
EMACement, Dental
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2
EMACement, DentalDental2
KLEAgent, Tooth Bonding, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023649000
K063444000
K131248000
K890464000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023649000VITIQUE SYSTEMDmg USA, Inc.2003-01-17EMA
K063444000TOTAL ETCH BONDING AGENTDmg USA, Inc.2007-03-20KLE
K131248000ETCH GELDmg America, LLC2013-07-11KLE
K890464000ZENITH 40% PHOSPHORIC ACID GELForemost Dental Mfg., Inc.1989-02-13EBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDMG2130821PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-894-5505eanagnostos@dmg-america.com

Regulatory Flags#

DUNS number
320744915
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDMG2228071Ecosite Elements Pure Refill B12228072026-10-30
EDMG2228081Ecosite Elements Pure Refill A22228082026-10-30
EDMG2228091Ecosite Elements Pure Refill A32228092026-10-30
EDMG2228101Ecosite Elements Pure Refill A3.52228102026-10-30
EDMG2228121Ecosite Elements Layer Refill EB2228122026-10-30
EDMG2228131Ecosite Elements Layer Refill EL2228132026-10-30
EDMG2228141Ecosite Elements Layer Refill EM2228142026-10-30
EDMG2228151Ecosite Elements Layer Refill ED2228152026-10-30
EDMG2228161Ecosite Elements Highlight Refill Incisal2228162026-10-30
EDMG2228171Ecosite Elements Highlight Refill OA22228172026-10-30
EDMG2228181Ecosite Elements Highlight Refill White2228182026-10-30
EDMG2228191Ecosite Elements Highlight Refill Brown2228192026-10-30
EDMG2228201Ecosite Elements Pure Refill B12228202026-10-30
EDMG2228211Ecosite Elements Pure Refill A22228212026-10-30
EDMG2228221Ecosite Elements Pure Refill A32228222026-10-30
EDMG2228231Ecosite Elements Pure Refill A3.52222832026-10-30
EDMG2228251Ecosite Elements Layer Refill EB2228152026-10-30
EDMG2228261Ecosite Elements Layer Refill EL2228262026-10-30
EDMG2228271Ecosite Elements Layer Refill EM2228272026-10-30
EDMG2228281Ecosite Elements Layer Refill ED2228282026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998118227Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118234Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118241Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118258Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118265Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118623Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00197998118630Solventum™ Photac™ Fil Quick Aplicap™Solventum Germany GmbHEMA2026-11-05
00190746061363Acid EtchantAMERICAN ORTHODONTICS CORPORATIONKLE2026-10-30
00195062160110NX3Kerr CorporationEMA2026-10-29
00195062159787BreezeKerr CorporationEMA2026-10-27
00195062159794Breeze RMGIKerr CorporationEMA2026-10-27
06970006745660Light Cure Dental AdhesiveRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
06970006746568Phosphoric Acid Etching GelRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
06972220488958Light Cure Dental AdhesiveRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
00197998079917Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079955Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079962Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079986Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079993Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998080005Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998099984Solventum™ RelyX™Solventum Germany GmbHEMA2026-10-08
00197998226724Solventum™ Protemp™Solventum Germany GmbHEMA2026-10-08
00810000525799Predicta®PARKELL, INC.EBC2026-09-25
10810000525802Predicta®PARKELL, INC.EBC2026-09-25
00810118108082NuSmile BioCemNUSMILE, LTD.EMA2026-09-22
00766054002956CEMPOWERESSENTIAL DENTAL SYSTEMS, INC.EMA2026-09-21
00195062162565Cement-ItKerr CorporationEMA2026-07-29
00195062162572Cement-ItKerr CorporationEMA2026-07-29
00195062162589Cement-ItKerr CorporationEMA2026-07-29
00840456224366JMUJMU DENTAL, INCKLE2026-07-22