PULPDENT CAVITY PREPARATION IV— 510(k) K013411

Substantially Equivalent

Pulpdent Corp.

FDA 510(k) clearance K013411 for PULPDENT CAVITY PREPARATION IV, Substantially Equivalent on 2001-12-12. Applicant: Pulpdent Corp.. Device class: 2.

Clearance details

Applicant: Pulpdent Corp.
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2001-10-15
Decision date: 2001-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Pulpdent Corp.

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K020115 — PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM2002-02-28
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K994180 — PULPDENT CAVITY PREPARATION III2000-03-02

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