FDA.reportPublic FDA data

ALPHA-DENT® Cavity Varnish

Primary DI
D73540701010010
Brand
ALPHA-DENT® Cavity Varnish
Company
DENTAL TECHNOLOGIES, INC.
Model
407.0101.001
Catalog number
407.0101.001
Device description
ALPHA-DENT® Cavity Varnish is used to form a barrier to protect exposed dentin and reduce fluid leakage around the tooth restoration interface. Kit Contains: 1 x 14ml Varnish
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
LBHVarnish, Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955521000ALPHA-DENT COPAL CAVITY VARNISHWallace A. Erickson & Co.1996-01-24LBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D73540701010010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental cavity varnishA liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
847-677-5500info@dentaltech.com

Regulatory Flags#

DUNS number
148312838
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D73550100050020Alpha-Etch® 37501.0005.002501.0005.0022016-09-23
D73550100060020Alpha-Etch® 37501.0006.002501.0006.0022016-09-23
D73550101030020Alpha-Etch® 37501.0103.002501.0103.0022016-09-23
D73550101050020Alpha-Etch® 37501.0105.002501.0105.0022016-09-23
D73550102030020Alpha-Etch® 37501.0203.002501.0203.0022016-09-23
D73550102050020Alpha-Etch® 37501.0205.002501.0205.0022016-09-23
D73550112040020Alpha-Etch® 37501.1204.002501.1204.0022016-09-23
D73550112110020Alpha-Etch® 37501.1211.002501.1211.0022016-09-23
D73550112130020Alpha-Etch® 37501.1213.002501.1213.0022016-09-23
D73550301020010ALPHA-DENT® Etchant Liquid503.0102.001503.0102.0012016-09-23
D73550301030010ALPHA-DENT® Etchant Liquid503.0103.001503.0103.0012016-09-23
D73550302030010ALPHA-DENT® Etchant Liquid503.0203.001503.0203.0012016-09-23
D73550302050010ALPHA-DENT® Etchant Liquid503.0205.001503.0205.0012016-09-23
D73520000000010ALPHA-DENT® Self Cure Bonding Adhesive200.0000.001200.0000.0012016-09-23
D73520000010010ALPHA-DENT® Self Cure Bonding Adhesive200.0001.001200.0001.0012016-09-23
D73520001020010ALPHA-DENT® Self Cure Bonding Adhesive200.0102.001200.0102.0012016-09-23
D73520002020010ALPHA-DENT® Self Cure Bonding Adhesive200.0202.001200.0202.0012016-09-23
D73520600000010ALPHA-DENT® Light Cure Bonding Adhesive206.0000.001206.0000.0012016-09-23
D73520600010010ALPHA-DENT® Light Cure Bonding Adhesive206.0001.001206.0001.0012016-09-23
D73520601010010ALPHA-DENT® Light Cure Bonding Adhesive206.0101.001206.0101.0012016-09-23

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