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FDA 510(k)

BIO-C REPAIR

K-Number: K180185 · 2018-08-31

ApplicantAngelus Industria DE Produtos Odontologicos S/A
Decision Date2018-08-31
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-C REPAIR is the device name listed in this FDA 510(k) record. The listed applicant is Angelus Industria DE Produtos Odontologicos S/A. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K180185. 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 BIO-C REPAIR?

BIO-C REPAIR is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is Angelus Industria DE Produtos Odontologicos S/A. The 510(k) number is K180185.

When did BIO-C REPAIR receive FDA 510(k) clearance?

BIO-C REPAIR received FDA 510(k) clearance on 2018-08-31, under 510(k) number K180185.

Who is the listed applicant for BIO-C REPAIR?

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

What is the FDA product code for BIO-C REPAIR?

The FDA product code for BIO-C REPAIR is KIF.

Other records listing Angelus Industria DE Produtos Odontologicos S/A 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.

K201222Bio-C Repair Ion+K190537BIO-C Sealer Ion+K180199BIO-C TEMPK172701BIO-C SEALER

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

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

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