CeraPutty CP052

Primary DI
08806387893127
Brand
CeraPutty CP052
Company
Meta Biomed Co., Ltd.
Model
9312
Device description
CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent root canal repair and filling applications.It is made of Calcium silicate composite, zirconium dioxide which is a radiopaque agent, and a thickening agent.CeraPutty sets and hardens by the moisture inside the oral cavity. CeraPutty does not shrink during setting and demonstrates excellent physical properties.CeraPutty does not require additional mixing for procedures, and its white color which allows aesthetic treatment.Ceraputty is packaged in a preloaded syringe.
Published
2024-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EKQPreparer, Root Canal Endodontic
KIFResin, Root Canal Filling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKQPreparer, Root Canal EndodonticDental1
KIFResin, Root Canal FillingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232299000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232299000CeraPuttyMeta Biomed Co., Ltd.2023-09-29KIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806387893127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806387893127088063878931278806387893127

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688322841
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
08806387894049Metacem Set94042018-08-30
08806387894803Metapex Plus 0.894802021-04-16
08806387809388MG 04-15/40 LM09382025-08-26
08806387809395MG 06-15/40 LM09392025-08-26
08806387892090Meta Etchant92092016-09-19
08806387814603MX 02-1514602025-08-26
08806387814610MX 02-2014612025-08-26
08806387814627MX 02-2514622025-08-26
08806387814634MX 02-3014632025-08-26
08806387814641MX 02-3514642025-08-26
08806387814658MX 02-4014652025-08-26
08806387814665MX 04-1514662025-08-26
08806387814672MX 04-2014672025-08-26
08806387814689MX 04-2514682025-08-26
08806387814696MX 04-3014692025-08-26
08806387814702MX 04-3514702025-08-26
08806387814719MX 04-4014712025-08-26
08806387814726MX 06-1514722025-08-26
08806387814733MX 06-2014732025-08-26
08806387814740MX 06-2514742025-08-26

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Primary DI, Brand, Company table
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08809262954371VioSealSpident Co., Ltd.KIF2026-04-20
07898078652961BIO-C REPAIR Angelus Industria de Produtos Odontologicos S AKIF2026-03-25
D01060620118NA1AH Plus Jet Endodontic Sealer Syringe RefillDentsply De Trey GmbHKIF2025-03-31
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