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FDA 510(k)

SavDenTM MTA Root Canal Filling Materials

K-Number: K162661 · 2017-04-25

ApplicantTyds Biotech Incorporation
Decision Date2017-04-25
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SavDenTM MTA Root Canal Filling Materials is a medical device manufactured by Tyds Biotech Incorporation. It received FDA 510(k) clearance on 2017-04-25 under approval number K162661. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SavDenTM MTA Root Canal Filling Materials?

SavDenTM MTA Root Canal Filling Materials is a medical device that received FDA 510(k) clearance on 2017-04-25. It is manufactured by Tyds Biotech Incorporation. The 510(k) number is K162661.

When was SavDenTM MTA Root Canal Filling Materials approved by the FDA?

SavDenTM MTA Root Canal Filling Materials received FDA 510(k) clearance on 2017-04-25, under approval number K162661.

What company makes SavDenTM MTA Root Canal Filling Materials?

SavDenTM MTA Root Canal Filling Materials is manufactured by Tyds Biotech Incorporation.

What is the FDA product code for SavDenTM MTA Root Canal Filling Materials?

The FDA product code for SavDenTM MTA Root Canal Filling Materials is KIF.

Related Clinical Trials

NCT07615491 PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials RECRUITING NCT04945993 Tooth Retention After Root Canal Treatment With Endomethasone N ACTIVE_NOT_RECRUITING NCT07526818 Comparison of Manual and Mechanical Glide Path Techniques for Measuring Root Canal Length Using Standalone Apex Locator and an Endomotor With built-in Apex Locator. ACTIVE_NOT_RECRUITING NCT07388901 In Vivo Study on the Material Properties of iRoot SP and nRoot SP Root Canal Sealers RECRUITING NCT07500961 Novel Bone Substitute (ALBO-OS) in Patients With Periodontal Disease or Who Need Alveolar Preservation COMPLETED

Related Devices (Code: KIF)

K161239MTA2.2 MATERIALAvalon Biomed, Inc. K151047MTA Repair HPAngelus Industria DE Productos Odontologicos K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron Dental Specialties K152956Pulp Canal Sealer, Pulp Canal Sealer EWTSybron Dental Specialties K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesSybron Dental Specialties K170950Well-Root STVericom Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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