FDA.reportPublic FDA data

Ultrabrush

Primary DI
00789594000718
Brand
Ultrabrush
Company
YOUNG MICROBRUSH, LLC
Model
U1D
Catalog number
U1D
Device description
Microbrush M10 Sion Dispenser with Ultrabrush Bristle Brush Short Neck Applicators, 100 Strand, Fine 1.5mm, Blue, Kit
Published
2020-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
10789594000715PackageGS1100In Commercial Distribution
20789594000712PackageGS124In Commercial Distribution
00789594000718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1078959400071510789594000715
2078959400071220789594000712
00789594000718007895940007187895940007180789594000718

GMDN Terms#

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

Contacts#

Phone, Email table
PhoneEmail
+1 (866) 866-8698customerservice@younginnovations.com

Regulatory Flags#

DUNS number
929236305
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00789594000206MicrobrushMBX-SAMPLE2020-12-08
00789594000213MicrobrushMD-SAMPLE/72020-12-08
00789594000732SmartBands2915902020-12-08
00789594000749SmartBands2915912020-12-08
00789594000756SmartBands2915922020-12-08
00789594000763SmartBands2915932020-12-08
00789594000770ContactPro2917042020-12-08
00789594000787ContactPro2917052020-12-08
00789594000794ContactPro2917062020-12-08
00789594000800ContactPro2917072020-12-08
00789594000817ContactPro2917082020-12-08
00789594000824ContactPro2917092020-12-08
00789594000862ContactPro2917462020-12-08
00789594000879ContactPro2917472020-12-08
00789594000886ContactPro2917482020-12-08
00789594000893ContactPro2917492020-12-08
00789594000909ContactPro2917502020-12-08
00789594000916Smartview2918072020-12-08
00789594000985Micro-Stix2917842917842020-12-08
00789594001104Microbrush2925122925122022-08-16

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