FDA.reportPublic FDA data

Alpha-Flow®

Primary DI
D73510306020020
Brand
Alpha-Flow®
Company
DENTAL TECHNOLOGIES, INC.
Model
103.0602.002
Catalog number
103.0602.002
Device description
Alpha-Flow® is a radiopaque fluoride containing light cure resin-based micro-hybrid flowable composite. The specially formulated materials incorporates both a nano-sized filler for increased flexibility and superior polishability and a 0.7 micron filler for excellent strength and wear resistance. This special combination provides a material with extreme versatility for use in a wide range of procedures, including Class III and V cavity figurations and small Class I and II restorations. Alpha-flow® contains fluorescence to provide a duplication of the natural tooth surface. Kit Contains: 1 x 1.5g Composite syringe (Shade B1), 5 Syringe Applicator 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
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960667000CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDEWallace A. Erickson & Co.1996-07-02EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D73510306020020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. 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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