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FDA 510(k)

CERAMAGE UP

K-Number: K162261 · 2017-01-11

ApplicantShofu Dental Corporation
Decision Date2017-01-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAMAGE UP is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K162261. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERAMAGE UP?

CERAMAGE UP is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Shofu Dental Corporation. The 510(k) number is K162261.

When did CERAMAGE UP receive FDA 510(k) clearance?

CERAMAGE UP received FDA 510(k) clearance on 2017-01-11, under 510(k) number K162261.

Who is the listed applicant for CERAMAGE UP?

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

What is the FDA product code for CERAMAGE UP?

The FDA product code for CERAMAGE UP is EBF.

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Related Devices (Code: EBF)

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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