FDA.reportPublic FDA data

PIVOT Fine Cherry Prophy Pack Box 100

Primary DI
D0241100063
Brand
PIVOT Fine Cherry Prophy Pack Box 100
Company
Preventech
Model
1100063
Catalog number
1100063
Device description
PIVOT Fine Cherry Prophy Pack Box of 100 units each containing 1 Pivot Non-Latex Prophy Angle Soft Cup and 1 2.0g prophy cup of NEXT Fine Cherry Prophy Paste
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
EJRAgent, Polishing, Abrasive, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHKCup, ProphylaxisDental1
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100539000
K951016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100539000PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDEPreventive Technologies, Inc.2010-06-17EJR
K951016000DISPOSABLE PROPHYLAXIS ANGLEPreventive Technologies, Inc.1995-05-02EHK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0241100063PrimaryHIBCC0
D02411000633Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
DentifriceA substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
7048492416customerservice@preventech.com

Regulatory Flags#

DUNS number
090735093
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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Primary DI, Brand, Model table
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D024772283VELLAmini 5% Sodium Fluoride Varnish Melon Box 1007722837722832016-10-05

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