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FDA 510(k)

Orthocem, Ortho Bite

K-Number: K192682 · 2020-08-14

ApplicantDentscare Ltda
Decision Date2020-08-14
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Orthocem, Ortho Bite is the device name listed in this FDA 510(k) record. The listed applicant is Dentscare Ltda. It received FDA 510(k) clearance on 2020-08-14 under 510(k) number K192682. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orthocem, Ortho Bite?

Orthocem, Ortho Bite is a medical device that received FDA 510(k) clearance on 2020-08-14. The listed applicant is Dentscare Ltda. The 510(k) number is K192682.

When did Orthocem, Ortho Bite receive FDA 510(k) clearance?

Orthocem, Ortho Bite received FDA 510(k) clearance on 2020-08-14, under 510(k) number K192682.

Who is the listed applicant for Orthocem, Ortho Bite?

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

What is the FDA product code for Orthocem, Ortho Bite?

The FDA product code for Orthocem, Ortho Bite is DYH.

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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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