FDA.report

BioPure

Primary DI
D716BP156P0
Brand
BioPure
Company
TULSA DENTAL PRODUCTS LLC
Model
BPSYRNDL2
Catalog number
BP156P
Device description
BioPure MTAD Endo Starter System P
Published
2022-10-13
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

Related Records

Product Codes

CodeName
KJJCLEANSER, ROOT CANAL

Product Code Classifications

CodeDeviceSpecialtyClass
KJJCleanser, Root CanalUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D716BP156P1PrimaryHIBCC0
D716BP156P0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Root canal cleaning solutionA fluid or gel material intended to be used in dentistry to facilitate cleaning/irrigation of the root canal during/after endodontic instrumentation to remove the smear layer, pulpal tissue, necrotic materials, and bacteria from the root canal, before placement of the endodontic filling; it may also act as a lubricant to facilitate the passage of an instrument (e.g., file/rasp) into the root canal. It is typically available as a disinfecting solution (e.g., chlorhexidine, sodium hypochlorite solution) delivered into the canal with an irrigation needle, or similar device, providing mechanical and possibly chemical cleaning of the canal. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
942778564
Device count
48
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
true
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 DIBrandModelCatalogPublished
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
D716PUENDO71ProUltraPUENDO7PUENDO72016-10-07
D716PUENDO81ProUltraPUENDO8PUENDO82016-10-07
D716PUSINE11ProUltraPUSINE1PUSINE12016-10-07
D716PUSINE161ProUltra SINEPUSINE1-6PUSINE1-62016-11-11
D716PUSINE21ProUltraPUSINE2PUSINE22016-10-07
D716PUSINE31ProUltra SINEPUSINE3PUSINE32016-10-07
D716PUSINE41ProUltra SINEPUSINE4PUSINE42016-10-07
D716PUSINE51ProUltra SINEPUSINE5PUSINE52016-10-07
D716PUSINE61ProUltra SINEPUSINE6PUSINE62016-10-07
D716PUSURG11ProUltraPUSURG1PUSURG12016-10-07
D716PUSURG161ProUltraPUSURG1-6PUSURG1-62016-11-11
D716PUSURG21ProUltraPUSURG2PUSURG22016-10-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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
00860004740315HYBENX Advanced Dental DebridementEpien Medical, Inc.KJJ2023-05-08
00887919807223Brasseler USAPeter Brasseler Holdings, LLCKJJ2023-03-17
00887919807254Brasseler USAPeter Brasseler Holdings, LLCKJJ2023-03-17
00887919807285Brasseler USAPeter Brasseler Holdings, LLCKJJ2023-03-17
10850002458609Advance Dental ProductsThe Atlanta Dental Supply CompanyKJJ2023-02-10
20850015491119Endocyn Root Canal Irrigation SolutionSonoma Pharmaceuticals, Inc.KJJ2022-12-02