FDA.reportPublic FDA data

EndoCeramic Root Repair Material

Primary DI
10810138823238
Brand
EndoCeramic Root Repair Material
Company
Endo Direct LLC
Model
ECRRM
Published
2024-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K241457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241457000Vista BC PuttyInter-Med, Inc.2024-08-28KIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810138823238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081013882323810810138823238

GMDN Terms#

Term, Definition table
TermDefinition
Root canal obturation kitA collection of sterile dental devices, synthetic materials, and solutions designed to permanently prime, seal, and fill a tooth undergoing a root canal procedure. This device typically includes materials such as a primer (for bonding to the walls of the canal), a sealer (for bonding to the primer), and endodontic points and pellets (for the filling). This bonding process creates a monoblock filling resulting in increased resistance to bacteria penetration and fracture for root canal-treated teeth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125216703
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810138823450ProShape Cyclone 60/06 25mmPS6006252026-05-11
10810138823429ProShape Cyclone KD File, 55/06, 21mmSamplePS5506212026-04-13
10810138823436ProShape Cyclone KD File, 60/06, 21mmSamplePS6006212026-04-13
10810138823443ProShape Cyclone KD File, 55/06, 25mmSamplePS5506252026-04-13
10810138823382ProShape HT-Assorted PackSample2026-03-16
10810138823399ProShape One Assorted PackSample2026-03-16
10810138823405Proshape Cyclone Asst PackSample2026-03-16
10810138823412Proshape Conserve Asst PackSample2026-03-16
10810138823276RC MixEDRCMIX2025-03-03
10810138823269ProShape Orifice BarrierPSOS172025-01-13
10810138823245ProShape Path Size 13 21mmPSPATH212024-11-14
10810138823252ProShape Path Size 13 25mmPSPATH252024-11-14
10810138822255ProShape One Gutta Percha SmallSDGP250612023-07-15
10810138822262ProShape One Gutta Percha PrimarySDGP300612023-07-15
10810138822279ProShape One Gutta Percha MediumSDGP350612023-07-15
10810138822286ProShape One Gutta Percha LargeSDGP400612023-07-15
10810138822293ProShape One Paper Points SmallSDGP450612023-07-15
10810138822309ProShape One Paper Points PrimarySDGP500612023-07-15
10810138822316ProShape One Paper Points MediumSDPP20042023-07-15
10810138822323ProShape One Paper Points LargeSDPP25042023-07-15

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