FDA.reportPublic FDA data

Injectable Root Canal Bioceramic Sealer(nRoot SP)

Primary DI
06976329180409
Brand
Injectable Root Canal Bioceramic Sealer(nRoot SP)
Company
Enpunuo Biotechnology Co., Ltd
Model
NR SP-3
Published
2025-06-30
Public version status
New
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
KIFResin, Root Canal Filling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIFResin, Root Canal FillingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250710000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250710000Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.2025-06-11KIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976329180409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976329180409069763291804096976329180409

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

Regulatory Flags#

DUNS number
715461879
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976329180256Root canal repair materialsnRoot BP0.1g2025-10-31
06976329180263Root canal repair materialsnRoot BP0.1g×22025-10-31
06976329180270Root canal repair materialsnRoot BP0.1g×32025-10-31
06976329180287Root canal repair materialsnRoot BP0.1g×52025-10-31
06976329180294Root canal repair materialsnRoot BP0.25g2025-10-31
06976329180300Root canal repair materialsnRoot BP0.25g×22025-10-31
06976329180317Root canal repair materialsnRoot BP0.25g×32025-10-31
06976329180324Root canal repair materialsnRoot BP0.25g×52025-10-31
06976329180331Root canal repair materialsnRoot BP0.5g2025-10-31
06976329180348Root canal repair materialsnRoot BP0.5g×22025-10-31
06976329180355Root canal repair materialsnRoot BP1g2025-10-31
06976329180362Root canal repair materialsnRoot BP1g×22025-10-31
06976329180379Injectable Root Canal Bioceramic Sealer(nRoot SP)NR SP-0.52025-06-30
06976329180386Injectable Root Canal Bioceramic Sealer(nRoot SP)NR SP-12025-06-30
06976329180393Injectable Root Canal Bioceramic Sealer(nRoot SP)NR SP-22025-06-30
06976329180416Injectable Root Canal Bioceramic Sealer(nRoot SP)NR SP-52025-06-30
06976329180010Injectable Root Canal Bioceramic SealerNR SP-12024-06-21
06976329180027Injectable Root Canal Bioceramic SealerNR SP-32024-06-21
06976329180034Injectable Root Canal Bioceramic SealerNR SP-52024-06-21
06976329180041Injectable Root Canal Bioceramic SealerNR SP-0.52024-06-21

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
07290115050523BJM Root Canal SealerB.J.M. LABORATORIES LTDKIF2026-03-20
00195062152771ZenSeal ProKerr CorporationKIF2026-02-10
00850440008490Actacal Bioceramic SealerEngineered Endodontics, LLCKIF2026-01-02
08800123819730Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08800123819747Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08800123819754Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08809254459402Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08809254459419Well-Root PTVERICOM CO., LTD.KIF2025-11-27
06976329180256Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180263Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180270Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180287Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180294Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180300Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180317Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180324Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180331Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180348Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180355Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180362Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
E22116461MTA vptVOCO GmbHKIF2025-10-14