FDA.reportPublic FDA data

Ultrabrush

Primary DI
00789594000725
Brand
Ultrabrush
Company
YOUNG MICROBRUSH, LLC
Model
U2D
Catalog number
U2D
Device description
Microbrush M10 Sion Dispenser with Ultrabrush Bristle Brush Short Neck Applicators, 200 Strand, Regular 2.0mm, Green
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
10789594000722PackageGS1100In Commercial Distribution
20789594000729PackageGS124In Commercial Distribution
00789594000725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1078959400072210789594000722
2078959400072920789594000729
00789594000725007895940007257895940007250789594000725

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
00789594000442MicrobrushWMFP100WMFP1002020-12-08
00789594000459MicrobrushWMFP100-SWMFP100-S2020-12-08
00789594000466MicrobrushWMFY100WMFY1002020-12-08
00789594000473MicrobrushWMFY100-SWMFY100-S2020-12-08
00789594000480MicrobrushWMRB100WMRB1002020-12-08
00789594000497MicrobrushWMRB100-SWMRB100-S2020-12-08
00789594000503MicrobrushWMRG100WMRG1002020-12-08
00789594000510MicrobrushWMRG100-SWMRG100-S2020-12-08
00789594000527MicrobrushWMRPE100WMRPE1002020-12-08
00789594000534MicrobrushWMRPE100-SWMRPE100-S2020-12-08
00789594000541MicrobrushWMRPU100WMRPU1002020-12-08
00789594000558MicrobrushWMRPU100-SWMRPU100-S2020-12-08
00789594000565MicrobrushWMSF100WMSF1002020-12-08
00789594000572MicrobrushWMSF100-SWMSF100-S2020-12-08
00789594000206MicrobrushMBX-SAMPLE2020-12-08
00789594000213MicrobrushMD-SAMPLE/72020-12-08
00789594000732SmartBands2915902020-12-08
00789594000749SmartBands2915912020-12-08
00789594000756SmartBands2915922020-12-08
00789594000763SmartBands2915932020-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194403293AiraAIRA, LLCKXR2026-08-25
00810194403309AiraAIRA, LLCKXR2026-08-25
00810194403323AiraAIRA, LLCKXR2026-08-25
00810194403330AiraAIRA, LLCKXR2026-08-25
00840456202555JMUJMU DENTAL, INCKXR2026-07-27
00840456202562JMUJMU DENTAL, INCKXR2026-07-27
00840456202579JMUJMU DENTAL, INCKXR2026-07-27
00840456202586JMUJMU DENTAL, INCKXR2026-07-27
00840456202593JMUJMU DENTAL, INCKXR2026-07-27
00840456218006JMUJMU DENTAL, INCKXR2026-07-27
00840456218013JMUJMU DENTAL, INCKXR2026-07-27
00840456218020JMUJMU DENTAL, INCKXR2026-07-27
00840456218037JMUJMU DENTAL, INCKXR2026-07-27
00840456202401JMUJMU DENTAL, INCKXR2026-07-08
00840456223222JMUJMU DENTAL, INCKXR2026-07-08
00840456223239JMUJMU DENTAL, INCKXR2026-07-08
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