TPH Spectra+ Universal Composite Restorative— 510(k) K162107

Name: FDA 510(k) clearance K162107
Creator: U.S. Food and Drug Administration
Published: 2016-09-27

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K162107 for TPH Spectra+ Universal Composite Restorative, Substantially Equivalent on 2016-09-27. Applicant: Dentsply Sirona. Device class: 2.

Clearance details

Applicant: Dentsply Sirona
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2016-07-29
Decision date: 2016-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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K261246 — SRGC-062026-06-18

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