PULPDENT ENDOPREP II— 510(k) K961089

Substantially Equivalent

Pulpdent Corp.

FDA 510(k) clearance K961089 for PULPDENT ENDOPREP II, Substantially Equivalent on 1996-04-23. Applicant: Pulpdent Corp.. Device class: 1.

Clearance details

Applicant: Pulpdent Corp.
Product code: Code EKL
Device class: Class 1
Regulation: 21 CFR 872.3840
Advisory panel: Dental
Date received: 1996-03-19
Decision date: 1996-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKL

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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.