FDA.reportPublic FDA data

Brush No.24

Primary DI
04548190107629
Brand
Brush No.24
Company
TOKUYAMA DENTAL CORPORATION
Model
10762
Device description
Brush for composite
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXRApplicator, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04548190107629PrimaryGS10
94548190107622Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04548190107629045481901076294548190107629
9454819010762294548190107622

GMDN Terms#

Term, Definition table
TermDefinition
Dental material application tool, reusableA hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-378-3548info@tokuyama-us.com

Regulatory Flags#

DUNS number
693552176
Device count
5
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04548190102242OMNICHROMA FLOW102242020-11-14
04548190201723TOKUSO Resin Hardner II201722021-06-25
04548190102228OMNICHROMA BLOCKER FLOW102222020-03-31
04548190101177OMNICHROMA BLOCKER101172018-09-10
04548190101276OMNICHROMA BLOCKER101272018-09-10
04548190101313OMNICHROMA BLOCKER101312018-04-02
04548190101337OMNICHROMA BLOCKER101332018-05-15
04548190101412OMNICHROMA101412018-09-10
04548190101511OMNICHROMA101512018-09-10
04548190131105Estelite Sigma Quick 131102016-09-23
04548190131112Estelite Sigma Quick 131112016-09-23
04548190131129Estelite Sigma Quick 131122016-09-23
04548190131136Estelite Sigma Quick131132016-09-23
04548190131143Estelite Sigma Quick 131142016-09-23
04548190131150Estelite Sigma Quick 131152016-09-23
04548190131167Estelite Sigma Quick131162016-09-23
04548190131174Estelite Sigma Quick 131172016-09-23
04548190131181Estelite Sigma Quick 131182016-09-23
04548190131198Estelite Sigma Quick 131192016-09-23
04548190131204Estelite Sigma Quick 131202016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D1257500B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502T4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502W4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125902D2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125902TLG1002Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903D2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903T2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903TLL1002Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904D2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904T2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904TWT1002Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125921B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125921G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21