FDA.reportPublic FDA data

Traxodent Tips

Primary DI
00348783002034
Brand
Traxodent Tips
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9007089
Device description
Unit- Dose Syringe Dispenser Qty 3
Published
2022-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00348783002034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783002034003487830020343487830020340348783002034

GMDN Terms#

Term, Definition table
TermDefinition
Dental material cartridge-plunging applicator, single-componentA hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014789663
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783011913Poli-Pro Disks20190702026-05-26
00348783011937Poli-Pro Disks20190712026-05-26
00348783011951Poli-Pro Disks20190732026-05-26
00348783006919Premier Scalers056332026-05-06
00348783006971Premier Scalers056922026-05-06
00348783006988Premier Scalers056942026-05-06
00348783006995Premier Scalers056952026-05-06
00348783007251Premier Scalers90614002026-05-06
00348783007268Premier Scalers90614012026-05-06
00348783007275Premier Scalers90614022026-05-06
00348783007299Premier Scalers90614202026-05-06
00348783007329Premier Scalers90614232026-05-06
00348783007374Premier Scalers10046862026-05-06
00348783007398Premier Scalers10046882026-05-06
00348783007435Premier Scalers10046952026-05-06
00348783009422Premier Spreader10038662026-05-06
00348783009439Premier Spreader10038682026-05-06
00348783009446Premier Spreader10038692026-05-06
00348783009460Premier Spreader10038712026-05-06
00348783009484Premier Spreader10038732026-05-06

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