FDA.reportPublic FDA data

NEXT Medium Mint Prophy Paste Box 200

Primary DI
D024220023
Brand
NEXT Medium Mint Prophy Paste Box 200
Company
Preventech
Model
220023
Catalog number
220023
Device description
NEXT Medium Mint Prophylaxis Paste Box of 200 2.0g prophy cup units used for dental prophylaxis 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
EJRAgent, Polishing, Abrasive, Oral Cavity

Product Code Classifications#

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

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
D024220023PrimaryHIBCC0
D0242200233Unit 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
200
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D024772105VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 357721057721052016-10-05
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
D024772223VELLAmini 5% Sodium Fluoride Varnish Strawberry Box 357722237722232016-10-05
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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