SPECTRUM 800 CURING UNIT— 510(k) K982318

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K982318 for SPECTRUM 800 CURING UNIT, Substantially Equivalent on 1998-09-15. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1998-07-02
Decision date: 1998-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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