FDA.reportPublic FDA data

Defend

Primary DI
10843471130558
Brand
Defend
Company
Young Innovations, Inc.
Model
MB-1100
Catalog number
MB-1100
Device description
Disposable Micro-Applicators - Regular - Blue
Published
2022-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10843471130558PackageGS1100In Commercial Distribution
20843471130555PackageGS1160In Commercial Distribution
00843471130551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084347113055810843471130558
2084347113055520843471130555
00843471130551008434711305518434711305510843471130551

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 275-0020customerservice@defend.com

Regulatory Flags#

DUNS number
004193103
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
true
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
00840326426630Astek1002991002992026-05-11
00840326423851Astek19025190252025-03-17
00840326423868Astek19026190262025-03-17
00840326423875Astek19027190272025-03-17
00840326423882Astek19028190282025-03-17
00843471150061Astek19000190002022-10-18
00843471150078Astek19005190052022-10-18
00843471150085Astek19001190012022-10-18
00843471150092Astek19006190062022-10-18
00840326426586Plak Smacker2000622026-04-20
00840326426593Plak Smacker2000632026-04-20
00840326426609Plak Smacker2000642026-04-20
00840326426616Plak Smacker2000652026-04-20
00840326426623Plak Smacker2000662026-04-20
00840326426203Young Specialties2000-02-102000-02-102026-01-26
00840326426210Young Specialties2000-03-102000-03-102026-01-26
00840326426227Young Specialties2000-04-102000-04-102026-01-26
00840326426234Young Specialties2000-05-102000-05-102026-01-26
00840326426241Young Specialties2000-06-102000-06-102026-01-26
00840326426258Young Specialties2000-07-102000-07-102026-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208482416OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208482423OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208590500OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208590678OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208590494OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208482768OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-03-13
07615208488401OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208445596OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208445602OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208486254OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
07615208445947OptraSculptIVOCLAR VIVADENT AKTIENGESELLSCHAFTKXR2026-01-15
EKUR000967KA0Disposable brush tips (black)KURARAY NORITAKE DENTAL INC.KXR2025-08-22
EKUR000968KA0Disposable brush tips (white)KURARAY NORITAKE DENTAL INC.KXR2025-08-22
00883205021809Inspiral Brush TipULTRADENT PRODUCTS, INC.KXR2025-08-19
10818207025033Traxodent Gel Brush TipsVista DentalKXR2025-06-30
08800019116608NeoGlide Resin InstrumentsB& L Biotech, inc.KXR2025-06-18
08800019116615NeoGlide Resin InstrumentsB& L Biotech, inc.KXR2025-06-18
00789594000046MicrobrushYOUNG MICROBRUSH, LLCKXR2025-06-13
10789594000050MicrobrushYOUNG MICROBRUSH, LLCKXR2025-06-13
00359883002718Multi-Brush® (Yellow)DEN-MAT HOLDINGS, LLCKXR2025-03-12
00359883003449Multi-Brush® (Blue)DEN-MAT HOLDINGS, LLCKXR2025-03-12
00359883004019Temptation® 10L Syringe Mixing TipsDEN-MAT HOLDINGS, LLCKXR2025-03-12
D701T20G191Applicator TipsPULPDENT CORPORATIONKXR2024-12-03
EKUR001024KA1Applicator brush (fine<silver>)KURARAY NORITAKE DENTAL INC.KXR2024-08-26
EKUR001025KA0Applicator brush (endo<black>)KURARAY NORITAKE DENTAL INC.KXR2024-08-26
EKUR001221KA0Applicator brush (superfine<white>)KURARAY NORITAKE DENTAL INC.KXR2024-08-26
00000008857972RMORmo, Inc.KXR2024-08-12
D956DVNRSTI0DSI Veneer Stick Adhesive Tip Holders 16pcsD.S.I DENTAL SOLUTIONS LTDKXR2024-06-27
D974BSI20032BritedentBright Supply, Inc.KXR2024-06-07
20889989061455OrmcoORMCO CORPORATIONKXR2024-03-07