FDA.reportPublic FDA data

BIODENTINE

Primary DI
03760140703335
Brand
BIODENTINE
Company
SEPTODONT SAS SPECIALITES SEPTODONT
Model
01C0600
Catalog number
01C0600
Device description
Bioactive dentin substitute
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJKLiner, Cavity, Calcium Hydroxide
KIFResin, Root Canal Filling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJKLiner, Cavity, Calcium HydroxideDental2
KIFResin, Root Canal FillingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760140703335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760140703335037601407033353760140703335

GMDN Terms#

Term, Definition table
TermDefinition
Hygroscopic dental cementA substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(303) 665-7535usregulatoryaffairs@septodont.com

Regulatory Flags#

DUNS number
275273795
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00303620001434Septodont Multi-Use Dispenser01C20562025-05-29
14719871634322Biodentine Mixer01C072501C07252025-04-25
03760140703359RACEGEL01C050001C05002016-09-12
03760140703243CIMPAT PINK01E011001E01102016-09-12
03760140703250CIMPAT WHITE01E012001E01202016-09-12
07897990328435SeptoWedges Refill: 100 Asst. wooden wedges01C402001C40202022-12-19
07897990328459SeptoMatrix Sectional Refill: 50 assorted matrices01C401401C40142022-12-16
07897990328466SeptoMatrix Sectional Refill: 50 large matrices01C401501C40152022-12-16
07897990328473SeptoMatrix Sectional Refill: 50 medium matrices01C401601C40162022-12-16
07897990328480SeptoMatrix Sectional Refill: 50 small matrices01C401701C40172022-12-16
07897990328718SeptoPlus Mandrel Refill: 1 mandrel snap01C403101C40312022-12-19
07897990328725SeptoDiscs Kit: 120 assorted abrasive discs+ mandrel pop-on01C400101C40012022-12-16
07897990328732SeptoDiscs Refill:1/2” 50 assorted abrasive discs01C400201C40022022-12-16
07897990328749SeptoDiscs Refill:1/2” 50 coarse abrasive discs01C400301C40032022-12-16
07897990328756SeptoDiscs Refill:1/2” 50 medium abrasive discs01C400401C40042022-12-16
07897990328763SeptoDiscs Refill: 1/2” - 50 fine abrasive discs01C400501C40052022-12-16
07897990328770SeptoDiscs Refill: 1/2” - 50 extra fine abrasive discs01C400601C40062022-12-16
07897990329081SeptoWedges Refill: 100 wooden wedges n°1-yellow01C402101C40212022-12-19
07897990329098SeptoWedges Refill: 100 wooden wedges n°2-blue01C402201C40222022-12-19
07897990329104SeptoWedges Refill: 100 wooden wedges n°3-red01C402301C40232022-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518345106One-Fil Putty InjectableMEDICLUS CO.,LTDKIF2026-05-21
06972902583292C-RootBeijing C-Root Dental Medical Devices Co., LTD.KIF2026-05-15
06972902583308C-RootBeijing C-Root Dental Medical Devices Co., LTD.KIF2026-05-15
08809518341252One-FilMEDICLUS CO.,LTDKIF2026-05-11
08809518343706One-Fil PuttyMEDICLUS CO.,LTDKIF2026-05-11
08404535015126Brasseler USAPeter Brasseler Holdings, LLCKIF2026-04-29
08809518346608CanalPro CalciSealMEDICLUS CO.,LTDKIF2026-04-23
08809262954371VioSealSpident Co., Ltd.KIF2026-04-20
07898078652961BIO-C REPAIR Angelus Industria de Produtos Odontologicos S AKIF2026-03-25
E22116461MTA vptVOCO GmbHKIF2025-10-14
D01060620118NA1AH Plus Jet Endodontic Sealer Syringe RefillDentsply De Trey GmbHKIF2025-03-31
D690220112SSW ENDOSs White Burs, Inc.KIF2025-02-19
06976329180010Injectable Root Canal Bioceramic SealerEnpunuo Biotechnology Co., LtdKIF2024-06-21
07649988156618OdneFillOdne AGKIF2024-01-31
00195062076374ZenSealKerr CorporationKIF2023-09-01
00195062076381ZenSealKerr CorporationKIF2023-09-01
00818365020713EdgeTaper Platinum™US ENDODONTICS, LLCKIF2023-06-25
00818365020720EdgeTaper Platinum™US ENDODONTICS, LLCKIF2023-06-25
00818365020737EdgeTaper Platinum™US ENDODONTICS, LLCKIF2023-06-25
00818365020744EdgeTaper Platinum™US ENDODONTICS, LLCKIF2023-06-25
00818365020751EdgeTaper Platinum™US ENDODONTICS, LLCKIF2023-06-25
00818365026746EdgeBioCeramic™US ENDODONTICS, LLCKIF2023-06-25
08800071200017CleaniCalMARUCHIEJK2023-05-16
10818207023183RE-GEN Bioactive EndoSealerVista DentalKIF2023-05-02
10850002458654Advance Dental ProductsThe Atlanta Dental Supply CompanyKIF2023-02-10
D9673000110ApaCal ARTPREVEST DENPRO LIMITEDEJK2023-01-03
D9673000510Cal LCPREVEST DENPRO LIMITEDEJK2023-01-03
D9674000110Nanoseal SPREVEST DENPRO LIMITEDKIF2023-01-03
D9674000510CalplusPREVEST DENPRO LIMITEDKIF2023-01-03
D967400060CalplusPREVEST DENPRO LIMITEDKIF2023-01-03