Alpha-Etch® 37

Primary DI
D73550100060020
Brand
Alpha-Etch® 37
Company
DENTAL TECHNOLOGIES, INC.
Model
501.0006.002
Catalog number
501.0006.002
Device description
Alpha-Etch® 37 is a 37% phosphoric acid etchant designed for use on both dentin and enamel. The ideal viscosity of the gel formula stays where placed and will not flow onto exposed surrounding tissue. All formulas rinse away clean without leaving any residue. Available in blue and green color. Kit Contains: 4 x 4g Syringe (Green), 20 Syringe Tips
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
K984503000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984503000ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000Wallace A. Erickson & Co.1999-02-26KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D73550100060020PrimaryHIBCC0
D73550102040020Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental tooth-etching solutionAn acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. 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
4
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
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
D73520601020010ALPHA-DENT® Light Cure Bonding Adhesive206.0102.001206.0102.0012016-09-23

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