ORALUBE— 510(k) K090457

Substantially Equivalent

Pulpdent Corporation

FDA 510(k) clearance K090457 for ORALUBE, Substantially Equivalent on 2009-05-21. Applicant: Pulpdent Corporation. Device class: 1.

Clearance details

Applicant: Pulpdent Corporation
Product code: Code ONK
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 2009-02-23
Decision date: 2009-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, 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.