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FDA 510(k)

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)

K-Number: K212475 · 2022-05-13

ApplicantPrevest Denpro Limited
Decision Date2022-05-13
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) is the device name listed in this FDA 510(k) record. The listed applicant is Prevest Denpro Limited. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K212475. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)?

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Prevest Denpro Limited. The 510(k) number is K212475.

When did Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) receive FDA 510(k) clearance?

Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) received FDA 510(k) clearance on 2022-05-13, under 510(k) number K212475.

Who is the listed applicant for Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)?

The FDA 510(k) record lists Prevest Denpro Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)?

The FDA product code for Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) is EJK.

Other records listing Prevest Denpro Limited as applicant

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Related Devices (Code: EJK)

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.

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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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