Alpha-Ease®

Primary DI
D73540801010020
Brand
Alpha-Ease®
Company
DENTAL TECHNOLOGIES, INC.
Model
408.0101.002
Catalog number
408.0101.002
Device description
Alpha-Ease® is a Hema/Gluteraldehyde desensitizer indicated for use on sensitive cavity preparations prior to the application of restorative material. It provides a physiological seal within the dentinal tubules by polymerization with the proteins in the tubules. The material provides virtually immediate relief from pain caused by hypersensitivity and is formulated with an antimicrobial to prevent microleakage. Kit Contains: 1 x 7ml Bottle
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
K960365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960365000ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)Wallace A. Erickson & Co.1996-03-28KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D73540801010020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental coating, tooth-desensitizingA substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. 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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