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)

MTA2 ROOT AND PULP MATERIALS

K-Number: K122892 · 2012-12-11

ApplicantAvalon Biomed, Inc.
Decision Date2012-12-11
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MTA2 ROOT AND PULP MATERIALS is the device name listed in this FDA 510(k) record. The listed applicant is Avalon Biomed, Inc.. It received FDA 510(k) clearance on 2012-12-11 under 510(k) number K122892. 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 MTA2 ROOT AND PULP MATERIALS?

MTA2 ROOT AND PULP MATERIALS is a medical device that received FDA 510(k) clearance on 2012-12-11. The listed applicant is Avalon Biomed, Inc.. The 510(k) number is K122892.

When did MTA2 ROOT AND PULP MATERIALS receive FDA 510(k) clearance?

MTA2 ROOT AND PULP MATERIALS received FDA 510(k) clearance on 2012-12-11, under 510(k) number K122892.

Who is the listed applicant for MTA2 ROOT AND PULP MATERIALS?

The FDA 510(k) record lists Avalon Biomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTA2 ROOT AND PULP MATERIALS?

The FDA product code for MTA2 ROOT AND PULP 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Avalon Biomed, Inc. as applicant

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.

K161239MTA2.2 MATERIAL

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.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

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.

↑