FDA.reportPublic FDA data

Enamelize

Primary DI
D7799060000
Brand
Enamelize
Company
COSMEDENT, INC.
Model
906000
Catalog number
906000
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K862912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K862912000RENAMELIZE POLISHING PASTECosmedent, Inc.1986-08-12EJR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7799060000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive powderA dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices. It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, the cleaning of orthodontic appliances (bands and brackets), the removal of adhesive residue, and the cleaning of implants prior to loading. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113911689
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7796611010PorcelEtch6611016611012016-09-22
D7796631010PorcelEtch6631016631012016-09-22
D7796631020PorcelEtch6631026631022016-09-22
D7796631030CompositeEtch6631036631032016-09-22
D7796631040PorcelEtch6631046631042016-09-22
D7796040153Prevue Refill Kit6040156040152016-09-22
D7799061010Enamelize9061019061012016-09-22
D7799061040Porcelize9061049061042016-09-22
D7799061050Porcelize9061059061052016-09-22
D7799061021Porcelize Kit9061022020-01-21
D7796541030Complete Dual-Cure Catalyst6541036541032016-09-22
D7796541040Complete Unfilled Resin6541046541042016-09-22
D7796061A20Renamel® Microhybrid6061A26061A22016-09-22
D7796062A21Renamel® Microhybrid6062A26062A22016-09-22
D7796062B21Renamel® Microhybrid6062B26062B22016-09-22
D7796062MI1Renamel® Microhybrid6062MI6062MI2016-09-22
D779100ROD1IPC Off-Angle Long100ROD2023-09-12
D77990110114ResinKeeper9011012020-02-17
D77970110W0Renamel® Flowable Microhybrid70110W70110W2016-09-22
D7797011A10Renamel® Flowable Microhybrid7011A17011A12016-09-22

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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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