FDA 510(k)

Orthocem, Ortho Bite

K-Number: K192682 · 2020-08-14

Decision Date2020-08-14

Product CodeDYH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Orthocem, Ortho Bite is a medical device manufactured by Dentscare Ltda. It received FDA 510(k) clearance on 2020-08-14 under approval 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. It is manufactured by Dentscare Ltda. The 510(k) number is K192682.

When was Orthocem, Ortho Bite approved by the FDA?

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

What company makes Orthocem, Ortho Bite?

Orthocem, Ortho Bite is manufactured by Dentscare Ltda.

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.