Cleared Traditional

K790586 - CHEMBOND
(FDA 510(k) Clearance)

K790586 · L.D. Caulk Co. · Dental device
May 1979
Decision
50d
Days
Class 2
Risk

K790586 is an FDA 510(k) clearance for the CHEMBOND. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by L.D. Caulk Co. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1979, 50 days after receiving the submission on March 27, 1979.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K790586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1979
Decision Date May 16, 1979
Days to Decision 50 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II - Special Controls
CFR Regulation 21 CFR 872.3275