Orthocem, Ortho Bite
FDA 510(k) K192682 · Dentscare Ltda
510(k) numberK192682
Submission
- Device name
- Orthocem, Ortho Bite
- Applicant
- Dentscare Ltda
Joinville, BR - Received
- September 26, 2019
- Decision date
- August 14, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Orthocem, Ortho Bite cleared by the FDA?
Orthocem, Ortho Bite (K192682) received a 510(k) decision of Substantially Equivalent on August 14, 2020, 323 days after the submission was received.
What is the product code of K192682?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.