FDA.reportPublic FDA data

QuikGlaze

Primary DI
D816200130GB0
Brand
QuikGlaze
Company
ALL DENTAL PRODX
Model
200130GB
Device description
A material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D816200130GB0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental restorative material varnishA liquid substance used to cover dental filling material in the initial setting period after application typically to prevent moisture infiltration (especially when a dental silicate or glass ionomer cement is used as a filling material). The device typically consists of dissolved artificial resins. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit78 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-647-7639kateliddle@alldentalprodx.com

Regulatory Flags#

DUNS number
002287223
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8161447000Bite Buddy1447002016-09-20
D8161430200TEMP TABS TRUE BLUE1430202016-09-20
D8161430330TEMP TABS NATURAL1430332016-09-20
D8161447001Bite Buddy1447002016-09-20

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