FDA.reportPublic FDA data

NEXT Coarse Cinnamon Prophy Paste Box 200

Primary DI
D024220173
Brand
NEXT Coarse Cinnamon Prophy Paste Box 200
Company
Preventech
Model
220173
Catalog number
220173
Device description
NEXT Coarse Cinnamon Prophy Paste Box of 200 2.0g prophy cup units 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
D024220173PrimaryHIBCC0
D0242201733Unit 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMICESA01Ena ShinyMICERIUM SPAEJR2025-11-07
EMICESB01Ena ShinyMICERIUM SPAEJR2025-11-07
00190707191177Ortho Technology®Ortho Organizers, Inc.EJR2025-10-23
17310236901089ProphyCare HApDirecta ABEJR2025-09-01
10304040192778Henry ScheinHENRY SCHEIN, INC.EJR2025-07-02
07615208479195VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479201VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479218VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479225VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479232VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479249VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479379VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208480054VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
TQ26126191191Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191201Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191211Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191221Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191231Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191251Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191261Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191271Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191281Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191291Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191301Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191311Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191321Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191331Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191341Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191351Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191361Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31