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FDA 510(k)

DIA-ROOT BIO Sealer

K-Number: K200175 · 2020-06-25

ApplicantDiaDent Group International
Decision Date2020-06-25
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIA-ROOT BIO Sealer is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2020-06-25 under 510(k) number K200175. 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 DIA-ROOT BIO Sealer?

DIA-ROOT BIO Sealer is a medical device that received FDA 510(k) clearance on 2020-06-25. The listed applicant is DiaDent Group International. The 510(k) number is K200175.

When did DIA-ROOT BIO Sealer receive FDA 510(k) clearance?

DIA-ROOT BIO Sealer received FDA 510(k) clearance on 2020-06-25, under 510(k) number K200175.

Who is the listed applicant for DIA-ROOT BIO Sealer?

The FDA 510(k) record lists DiaDent Group International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIA-ROOT BIO Sealer?

The FDA product code for DIA-ROOT BIO Sealer 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.

NCT07608939Postoperative Pain After Root Canal Treatment Using Different Root Canal SealersNOT_YET_RECRUITINGNCT07684014Evaluation of Bone Healing After Obturation With Dia-Root Bio Sealer (Calcium Silicate-based Sealer CSBS) Using Three Obturation TechniquesSUSPENDED

Other records listing DiaDent Group International 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.

K261166DIA-CEMK261093DIAFILK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)K254112Dia-X Sil BiteK231552Dia-CemK220804Dia-X Bond Universal

View all 21 devices →

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.

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