Cleared Traditional

K882125 - CENTRIX TRI-LAMINATE POST SYSTEM (FDA 510(k) Clearance)

Aug 1988
Decision
83d
Days
Class 1
Risk

K882125 is an FDA 510(k) clearance for the CENTRIX TRI-LAMINATE POST SYSTEM. This device is classified as a Post, Root Canal (Class I - General Controls, product code ELR).

Submitted by Centrix, Inc. (Milford, US). The FDA issued a Cleared decision on August 11, 1988, 83 days after receiving the submission on May 20, 1988.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3810.

Submission Details

510(k) Number K882125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1988
Decision Date August 11, 1988
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code ELR — Post, Root Canal
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.3810