FDA.reportPublic FDA data

Contax Intro Kit + Activator

Primary DI
EDMG2202821
Brand
Contax Intro Kit + Activator
Company
DMG Chemisch-Pharmazeutische Fabrik GmbH
Model
220282
Catalog number
220282
Device description
Self etching, self conditioning adhesive system. Content: 1 bottle @ 5 ml Contax-Primer, 1 bottle @ 5 ml Contax-Bond, 1 bottle @ 5 ml Contax-Activator, 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
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023649000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023649000VITIQUE SYSTEMDmg USA, Inc.2003-01-17EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDMG2202821PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Close bottles immediately after use
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature36 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

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Primary DI, Brand, Company table
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06972220488958Light Cure Dental AdhesiveRizhao HuGe Biomaterials Company, Ltd.KLE2026-10-25
00840456224366JMUJMU DENTAL, INCKLE2026-07-22
00840456224441JMUJMU DENTAL, INCKLE2026-07-22
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00348783015607Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
00348783015614Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
00850194007763Zr-P BottleVista DentalKLE2026-06-04
08809518342105Hi-Bond UniversalMEDICLUS CO.,LTDKLE2026-06-01
00197998024269Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024276Solventum™Solventum Germany GmbHKLE2026-05-08
00197998024290Solventum™Solventum Germany GmbHKLE2026-05-08
J017CVMLP0140VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
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08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
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306058610668163M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
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D0019064170LucitoneDentsply International Inc.KLE2025-07-01
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCKLE2025-03-12
00195062068508OptiBond Universal 360Kerr CorporationKLE2024-06-25
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