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FDA 510(k)

EDS Bioceramic Sealer (Bioseal)

K-Number: K202281 · 2021-02-12

ApplicantEssential Dental Systems
Decision Date2021-02-12
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EDS Bioceramic Sealer (Bioseal) is the device name listed in this FDA 510(k) record. The listed applicant is Essential Dental Systems. It received FDA 510(k) clearance on 2021-02-12 under 510(k) number K202281. 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 EDS Bioceramic Sealer (Bioseal)?

EDS Bioceramic Sealer (Bioseal) is a medical device that received FDA 510(k) clearance on 2021-02-12. The listed applicant is Essential Dental Systems. The 510(k) number is K202281.

When did EDS Bioceramic Sealer (Bioseal) receive FDA 510(k) clearance?

EDS Bioceramic Sealer (Bioseal) received FDA 510(k) clearance on 2021-02-12, under 510(k) number K202281.

Who is the listed applicant for EDS Bioceramic Sealer (Bioseal)?

The FDA 510(k) record lists Essential Dental Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDS Bioceramic Sealer (Bioseal)?

The FDA product code for EDS Bioceramic Sealer (Bioseal) is KIF.

Other records listing Essential Dental Systems 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.

K223340EDS Calculus Softener TURBO CRK152691EDS Universal Cement

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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