PIVOT Medium Bubblegum Prophy Pack Box 100

Primary DI
D02411001033
Brand
PIVOT Medium Bubblegum Prophy Pack Box 100
Company
Preventech
Model
1100103
Catalog number
1100103
Device description
PIVOT Medium Bubblegum Prophy Pack Box of 100 units each containing 1 PIVOT Non-Latex Prophy Angle Soft Cup and 1 2.0g prophy cup of NEXT Medium Bubblegum Prophy Paste
Published
2023-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K100539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100539000PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDEPreventive Technologies, Inc.2010-06-17EJR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0241100103PrimaryHIBCC0
D02411001033Unit 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7048492416customerservice@preventech.com

Regulatory Flags#

DUNS number
090735093
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

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

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