PULPDENT OX-OUT— 510(k) K972445

Substantially Equivalent

Pulpdent Corp.

FDA 510(k) clearance K972445 for PULPDENT OX-OUT, Substantially Equivalent on 1997-10-02. Applicant: Pulpdent Corp.. Device class: 2.

Clearance details

Applicant: Pulpdent Corp.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1997-06-30
Decision date: 1997-10-02
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.