FDA.reportPublic FDA data

Complete Bonding Kit

Primary DI
D7796540053
Brand
Complete Bonding Kit
Company
COSMEDENT, INC.
Model
654005
Catalog number
654005
Device description
Complete Bonding Kit includes 1 bottle of Primer/Unfilled Resin, 1 bottle of Dual-Cure Catalyst, 1 bottle of Unfilled Resin, one #1 brush/straight; and one #1 brush/bent in Tray.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7796540053PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite adhesive kitA collection of devices intended to be used to bond attachments such as hooks or buttons to the teeth and/or to an orthodontic aligner during dental or orthodontic teeth adjustment. The adhesives are typically based on light-cured bonding composites (e.g., 400-500nm range). The contents of this kit may include etchant, bonding resin, bonding paste, spatula, brushes, and a paper pad. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113911689
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7796611010PorcelEtch6611016611012016-09-22
D7796631010PorcelEtch6631016631012016-09-22
D7796631020PorcelEtch6631026631022016-09-22
D7796631030CompositeEtch6631036631032016-09-22
D7796631040PorcelEtch6631046631042016-09-22
D7796040153Prevue Refill Kit6040156040152016-09-22
D7799060000Enamelize9060009060002016-09-22
D7799061010Enamelize9061019061012016-09-22
D7799061040Porcelize9061049061042016-09-22
D7799061050Porcelize9061059061052016-09-22
D7799061021Porcelize Kit9061022020-01-21
D7796541030Complete Dual-Cure Catalyst6541036541032016-09-22
D7796541040Complete Unfilled Resin6541046541042016-09-22
D7796061A20Renamel® Microhybrid6061A26061A22016-09-22
D7796062A21Renamel® Microhybrid6062A26062A22016-09-22
D7796062B21Renamel® Microhybrid6062B26062B22016-09-22
D7796062MI1Renamel® Microhybrid6062MI6062MI2016-09-22
D779100ROD1IPC Off-Angle Long100ROD2023-09-12
D77990110114ResinKeeper9011012020-02-17
D77970110W0Renamel® Flowable Microhybrid70110W70110W2016-09-22