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FDA 510(k)

Dia-Proseal

K-Number: K182009 · 2019-09-26

ApplicantDiaDent Group International
Decision Date2019-09-26
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dia-Proseal 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 2019-09-26 under 510(k) number K182009. 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-Proseal?

Dia-Proseal is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is DiaDent Group International. The 510(k) number is K182009.

When did Dia-Proseal receive FDA 510(k) clearance?

Dia-Proseal received FDA 510(k) clearance on 2019-09-26, under 510(k) number K182009.

Who is the listed applicant for Dia-Proseal?

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-Proseal?

The FDA product code for Dia-Proseal is KIF.

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

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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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