FDA.reportPublic FDA data

Kolorz Prophylaxis Paste

Primary DI
D0337884011
Brand
Kolorz Prophylaxis Paste
Company
DMG AMERICA, LLC
Model
788401
Catalog number
788401
Device description
Kolorz Prophylaxis Paste - Triple Mint, Fine Grit (200 Unit-Dose Cups)
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0337884011PrimaryHIBCC0
D0337884010Unit 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
2018945505gvazquez@dmg-america.com

Regulatory Flags#

DUNS number
106792427
Device count
200
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00325047000005DMG2206002206002025-11-06
D0337884101Kolorz Prophylaxis Paste7884102025-06-04
D0337884111Kolorz Prophylaxis Paste7884112025-06-04
D0337884100Kolorz Prophylaxis Paste7884102025-06-04
D0337884110Kolorz Prophylaxis Paste7884112025-06-04
D0331430200TEMP TABS1430202025-04-18
D0331430330TEMP TABS1430332025-04-18
D033003619011ZenithDental61901003-619012016-09-23
D033003610961Zekrya Gingival Protector Kit003-61096003-610962022-12-12
D033003610971Zekrya Small Arc003-61097003-610972022-12-12
D033003610981Zekrya Large Arc003-61098003-610982022-12-12
D0337884021Kolorz Prophylaxis Paste7884027884022022-12-12
D0337884031Kolorz Prophylaxis Paste7884037884032022-12-12
D0337884041Kolorz Prophylaxis Paste7884047884042022-12-12
D0337884061Kolorz Prophylaxis Paste7884067884062022-12-12
D0337884071Kolorz Prophylaxis Paste7884077884072022-12-12
D0337884081Kolorz Prophylaxis Paste7884087884082022-12-12
D0337884091Kolorz Prophylaxis Paste7884097884092022-12-12
D0337884151Kolorz Prophylaxis Paste7884157884152022-12-12
D0337884161Kolorz Prophylaxis Paste7884167884162022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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EMICESB01Ena ShinyMICERIUM SPAEJR2025-11-07
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17310236901089ProphyCare HApDirecta ABEJR2025-09-01
10304040192778Henry ScheinHENRY SCHEIN, INC.EJR2025-07-02
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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
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