Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Tyds Biotech Incorporation. It received FDA 510(k) clearance on 2017-04-25 under 510(k) 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. The listed applicant is Tyds Biotech Incorporation. The 510(k) number is K162661.

When did SavDenTM MTA Root Canal Filling Materials receive FDA 510(k) clearance?

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

Who is the listed applicant for SavDenTM MTA Root Canal Filling Materials?

The FDA 510(k) record lists Tyds Biotech Incorporation as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07246512A Comparative Analysis of Biomaterials for Retrograde Filling in Apical Surgery.COMPLETEDNCT04757753Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled TrialACTIVE_NOT_RECRUITINGNCT04945993Tooth Retention After Root Canal Treatment With Endomethasone NACTIVE_NOT_RECRUITINGNCT07388901In Vivo Study on the Material Properties of iRoot SP and nRoot SP Root Canal SealersRECRUITINGNCT07526818Comparison 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_RECRUITINGNCT07541976Comparative Evaluation of Three Different Pulpotomy Agents in Primary MolarsACTIVE_NOT_RECRUITING

Related Devices (Code: KIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr CorporationK251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus 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.

↑