FDA.reportPublic FDA data

BioPure

Primary DI
D716BPSYRNDL21
Brand
BioPure
Company
TULSA DENTAL PRODUCTS LLC
Model
BPSYRNDL2
Catalog number
BPSYRNDL2
Device description
BioPure MTAD Empty Syringes
Published
2022-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KJJCLEANSER, ROOT CANAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJJCleanser, Root CanalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D716BPSYRNDL21PrimaryHIBCC0
D716BPSYRNDL20Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental irrigation/aspiration syringeA hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.

Regulatory Flags#

DUNS number
942778564
Device count
432
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D716GTPOSTFSAM1GT Post and DrillsGTPOSTFSAMGTPOSTFSAM2022-09-01
D716BP156L1BioPureBPSYRNDL2BP156L2022-10-13
D716BP156P1BioPureBPSYRNDL2BP156P2022-10-13
D716BP156SYS1BioPureBPSYRNDL2BP156SYS2022-10-13
D716BP288P1BioPureBPSYRNDL2BP288P2022-10-13
D716BP36L1BioPureBPSYRNDL2BP36L2022-10-13
D716BP36P1BioPureBPSYRNDL2BP36P2022-10-13
D716BP36SYS1BioPureBPSYRNDL2BP36SYS2022-10-13
D716BP48L1BioPureBPSYRNDL2BP48L2022-10-13
D716BP48P1BioPureBPSYRNDL2BP48P2022-10-13
D716BP48R1BioPureBPSYRNDL2BP48R2022-10-13
D716PIEZOFLOWREFILL1ProUltra PiezoFlowPIEZOFLOWREFILLPIEZOFLOWREFILL2022-10-18
D716PUENDO11ProUltraPUENDO1PUENDO12016-10-07
D716PUENDO151ProUltraPUENDO1-5PUENDO1-52016-11-11
D716PUENDO21ProUltraPUENDO2PUENDO22016-10-07
D716PUENDO31ProUltraPUENDO3PUENDO32016-10-07
D716PUENDO41ProUltraPUENDO4PUENDO42016-10-07
D716PUENDO51ProUltraPUENDO5PUENDO52016-10-07
D716PUENDO61ProUltraPUENDO6PUENDO62016-10-07
D716PUENDO681ProUltraPUENDO6-8PUENDO6-82016-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10818207024920Endo Sealer SolventVista DentalKJJ2026-04-22
10818207024944Endo Sealer Solvent SampleVista DentalKJJ2026-04-22
008101265062213D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKJJ2026-03-24
00810118106415Avalon Biomed NeoSolvNUSMILE, LTD.KJJ2025-03-19
00810118106422Avalon Biomed NeoSolvNUSMILE, LTD.KJJ2025-03-19
08404535011982BC SealerPeter Brasseler Holdings, LLCKJJ2025-03-17
10818207024937EdgeUtopi BC Solvent Vista DentalKJJ2025-03-17
10810138823276RC MixEndo Direct LLCKJJ2025-03-03
D6620708377810Patterson®PATTERSON DENTAL SUPPLY, INC.KJJ2024-05-08
D6620708377990Patterson®PATTERSON DENTAL SUPPLY, INC.KJJ2024-05-08
00840326420324Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420348Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420362Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420386Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420331Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420355Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420379Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420393Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
07630031730053Straumann PrefGelInstitut Straumann AGKJJ2023-09-30
10810138822668Endo Direct Sodium hypoclorite 3%Endo Direct LLCKJJ2023-07-15
10810138822675Endo Direct Sodium hypoclorite 6%Endo Direct LLCKJJ2023-07-15
10810138822682Endo Direct 17% EDTAEndo Direct LLCKJJ2023-07-15
00818365028870EdgeMix™US ENDODONTICS, LLCKJJ2023-06-25
00818365028979EdgeEndo®US ENDODONTICS, LLCKJJ2023-06-25
00818365029006EdgeEndo®US ENDODONTICS, LLCKJJ2023-06-25
10818207024340SmearOFF System (PS System)Vista DentalKJJ2023-06-09
10818207024357PS System - Chlor-Xtra Plus Bag (40mL)Vista DentalKJJ2023-06-09
10818207024401PS System - Chlor-Xtra Plus Bag (60mL)Vista DentalKJJ2023-06-09
10818207024418PS System - Chlor-Xtra Plus Bag (100mL)Vista DentalKJJ2023-06-09
00860004740322HYBENX Advanced Dental Debridement GelEpien Medical, Inc.KJJ2023-05-09