Cleared Traditional

K873153 - CAULK'S VPS CARTRIDGE SYSTEM
(FDA 510(k) Clearance)

Sep 1987
Decision
36d
Days
Class 1
Risk

K873153 is an FDA 510(k) clearance for the CAULK'S VPS CARTRIDGE SYSTEM. This device is classified as a Syringe, Restorative And Impression Material (Class I - General Controls, product code EID).

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on September 16, 1987, 36 days after receiving the submission on August 11, 1987.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K873153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1987
Decision Date September 16, 1987
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code EID — Syringe, Restorative And Impression Material
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.4565