FDA.reportPublic FDA data

Endogel

Primary DI
00859611006716
Brand
Endogel
Company
JORDCO INC
Model
EG-BP
Catalog number
EG-BP
Device description
Endodontic Lubricating Gel: Bulk Pack of 288 tubes
Published
2020-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KJJCleanser, Root Canal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJJCleanser, Root CanalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992484000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992484000RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNGJordco, Inc.1999-10-14KJJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859611006716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859611006716008596110067168596110067160859611006716

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
503-531-3904info@jordco.com

Regulatory Flags#

DUNS number
803063981
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859611006112EndoringERUL-sERUL-S2020-08-08
00859611006129EndoringERULX-SERULX-S2020-08-08
00859611006259EndoringERR-SERR-S2020-08-08
00859611006266EndoringERRFR-SERRFR-S2020-08-08
00859611006273EndoringERRFL-SERRFL-S2020-08-08
00859611006570EndoringERRFRRG-SERRFRRG-S2020-08-08
00859611006587EndoringERRFLRG-SERRFLRG-S2020-08-08
00859611006631EndoringERULRG-SERULRG-S2020-08-08
00859611006648EndoringERULXRG-SERULXRG-S2020-08-08
00859611006709EndoringER2SP-EX-SER2SP-EX-S2020-08-08
00859611006723EndoringER2-EX-SER2-EX-S2020-09-07
00859611006730EnodringER-EX-SER-EX-S2020-09-07
00859611006006EndogelEG-sEG-S2020-08-08
00859611006020EndoringER2-SER2-S2020-08-08
00859611006037EndoringER2V-SER2V-S2020-08-08
00859611006044EndoringER2Y-SER2Y-S2020-08-08
00859611006051EndoringER2G-SER2G-S2020-08-08
00859611006068EndoringER2VX-SER2VX-S2020-08-08
00859611006075EndoringER2BX-VER2BX-S2020-08-08
00859611006082EndoringER2GX-SER2GX-S2020-08-08

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