FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040156049
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702815
Catalog number
5702815
Device description
Maxima Spiral Flow Tips 100/Pk
Published
2022-03-31
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

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
10304040156046PrimaryGS10
00304040156049Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404015604610304040156046
00304040156049003040401560493040401560490304040156049

GMDN Terms#

Term, Definition table
TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
100
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
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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