FDA 510(k)

MTA Repair HP

K-Number: K151047 · 2016-08-31

ApplicantAngelus Industria DE Productos Odontologicos

Decision Date2016-08-31

Product CodeKIF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

MTA Repair HP is the device name listed in this FDA 510(k) record. The listed applicant is Angelus Industria DE Productos Odontologicos. It received FDA 510(k) clearance on 2016-08-31 under 510(k) number K151047. 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 MTA Repair HP?

MTA Repair HP is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is Angelus Industria DE Productos Odontologicos. The 510(k) number is K151047.

When did MTA Repair HP receive FDA 510(k) clearance?

MTA Repair HP received FDA 510(k) clearance on 2016-08-31, under 510(k) number K151047.

Who is the listed applicant for MTA Repair HP?

The FDA 510(k) record lists Angelus Industria DE Productos Odontologicos as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTA Repair HP?

The FDA product code for MTA Repair HP is KIF.

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 Corporation K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus Co., Ltd.

Official Source

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