FDA.reportPublic FDA data

Contax

Primary DI
EDMG2202831
Brand
Contax
Company
DMG Chemisch-Pharmazeutische Fabrik GmbH
Model
220283
Catalog number
220283
Device description
Contax Activator. Self etching, self conditioning adhesive system. Content: 1 bottle @ 5 ml Activator.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
EDMG2202831PackageHIBCC1In Commercial Distribution
EDMG2202830PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00190746061363Acid EtchantAMERICAN ORTHODONTICS CORPORATIONKLE2026-10-30
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
00840456224366JMUJMU DENTAL, INCKLE2026-07-22
00840456224441JMUJMU DENTAL, INCKLE2026-07-22
07615208570830Adhese 2 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2026-07-22
00348783015591Bond-PRPREMIER DENTAL PRODUCTS COMPANYKLE2026-06-10
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
J017CVMLP0240VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
J017CVMLPSET0VITA VM®LCVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftKLE2026-05-07
08809262954012FineEtchSpident Co., Ltd.KLE2026-04-20
08809262954029FineEtchSpident Co., Ltd.KLE2026-04-20
306058610668163M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
306058610669083M™ Adper™ Scotchbond™3M COMPANYKLE2026-04-17
506058610362573M™ Adper™3M COMPANYKLE2026-04-17
D0019064140LucitoneDentsply International Inc.KLE2025-07-01
D0019064150LucitoneDentsply International Inc.KLE2025-07-01
D0019064160LucitoneDentsply International Inc.KLE2025-07-01
D0019064170LucitoneDentsply International Inc.KLE2025-07-01
00359883004446MPa™ Max Adhesive with Chlorhexidine KitDEN-MAT HOLDINGS, LLCKLE2025-03-12
00195062068508OptiBond Universal 360Kerr CorporationKLE2024-06-25
07615208298536Monobond PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTKLE2024-01-24