Surgical and Prosthetic Trays— 510(k) K220791

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K220791 for Surgical and Prosthetic Trays, Substantially Equivalent on 2022-05-03. Applicant: Dentsply Sirona. Device class: 2.

Clearance details

Applicant: Dentsply Sirona
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2022-03-18
Decision date: 2022-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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K252248 — CEREC Tessera Abutment System2025-11-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.