FDA.reportPublic FDA data

Microbrush

Primary DI
00789594000534
Brand
Microbrush
Company
YOUNG MICROBRUSH, LLC
Model
WMRPE100-S
Catalog number
WMRPE100-S
Device description
Microbrush Disposable Micro-Applicators, World Spanish, M8 Regular 2.0mm, Peach
Published
2020-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10789594000531PackageGS1100Not in Commercial Distribution
20789594000538PackageGS1260In Commercial Distribution
00789594000534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1078959400053110789594000531
2078959400053820789594000538
00789594000534007895940005347895940005340789594000534

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00789594000770ContactPro2917042020-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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