FDA.reportPublic FDA data

PIVOT Non-Latex Disposable Prophy Angle Taper Brush Box 144

Primary DI
D0241100033
Brand
PIVOT Non-Latex Disposable Prophy Angle Taper Brush Box 144
Company
Preventech
Model
1100033
Catalog number
1100033
Device description
PIVOT Non-Latex Disposable Prophy Angle Taper Brush Box of 144 single use taper brushes for dental procedures
Published
2023-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHKCup, Prophylaxis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHKCup, ProphylaxisDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951016000DISPOSABLE PROPHYLAXIS ANGLEPreventive Technologies, Inc.1995-05-02EHK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0241100033PrimaryHIBCC0
D02411000333Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental-professional prophylaxis brush, single-useA non-sterile rotary dental instrument with natural or synthetic bristle brushes intended to be used by a dental hygienist and/or dentist to clean and polish teeth. It is designed to be attached to a powered dental handpiece which provides the necessary rotation. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
7048492416customerservice@preventech.com

Regulatory Flags#

DUNS number
090735093
Device count
144
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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D024772113VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 1007721137721132016-10-05
D024772115VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 1007721157721152016-10-05
D024772145VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 357721457721452016-10-05
D024772153VELLAmini 5% Sodium Fluoride Varnish Caramel Box 1007721537721532016-10-05
D024772155VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 1007721557721552016-10-05
D024772215VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 357722157722152016-10-05
D024772225VELLAmini 5% Sodium Fluoride Varnish Strawberry Case of 12 Boxes of 357722257722252016-10-05
D024772235VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 1007722357722352016-10-05
D024772245VELLAmini 5% Sodium Fluoride Varnish Strawberry Case of 12 Boxes of 1007722457722452016-10-05
D024772275VELLAmini 5% Sodium Fluoride Varnish Melon Case of 12 Boxes of 357722757722752016-10-05
D024772285VELLAmini 5% Sodium Fluoride Varnish Melon Case of 12 Boxes of 1007722857722852016-10-05
D024772103VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 357721037721032016-10-05
D024772143VELLAmini 5% Sodium Fluoride Varnish Caramel Box 357721437721432016-10-05
D024772213VELLAmini 5% Sodium Fluoride Varnish Spearmint Box 357722137722132016-10-05
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D024772233VELLAmini 5% Sodium Fluoride Varnish Spearmint Box 1007722337722332016-10-05
D024772243VELLAmini 5% Sodium Fluoride Varnish Strawberry Box 1007722437722432016-10-05
D024772273VELLAmini 5% Sodium Fluoride Varnish Melon Box 357722737722732016-10-05
D024772283VELLAmini 5% Sodium Fluoride Varnish Melon Box 1007722837722832016-10-05

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Primary DI, Brand, Company table
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