PULPDENT ENAMEL BONDING AGENT— 510(k) K911282

Substantially Equivalent

Pulpdent Corp.

FDA 510(k) clearance K911282 for PULPDENT ENAMEL BONDING AGENT, Substantially Equivalent on 1991-09-06. Applicant: Pulpdent Corp.. Device class: 2.

Clearance details

Applicant: Pulpdent Corp.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1991-03-19
Decision date: 1991-09-06
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
K014059 — PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE2002-02-27
K013411 — PULPDENT CAVITY PREPARATION IV2001-12-12

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