FDA.reportPublic FDA data

LuxaBond - Total Etch

Primary DI
EDMG2123841
Brand
LuxaBond - Total Etch
Company
DMG Chemisch-Pharmazeutische Fabrik GmbH
Model
212384
Catalog number
212384
Device description
Total Etch dual cure adhesive system. The perfect partner for all direct and indirect techniques. Content: 1 bottle @ 5 ml Pre-Bond, 1 bottle @ 5 ml Bond A, 1 bottle @ 5 ml Bond B, 1 syringe @ 2 ml DMG Etching Gel Medium Viscosity, Accessories.
Published
2016-09-23
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
K063444000
K131248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063444000TOTAL ETCH BONDING AGENTDmg USA, Inc.2007-03-20KLE
K131248000ETCH GELDmg America, LLC2013-07-11KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDMG2123841PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Close bottle immediately after use!
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit46 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
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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
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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