Cleared Traditional

K810977 - ENDODONTIC POST SYSTEMS
(FDA 510(k) Clearance)

K810977 · Preat Corp. · Dental device

May 1981

Decision

33d

Days

Class 1

Risk

K810977 is an FDA 510(k) clearance for the ENDODONTIC POST SYSTEMS. This device is classified as a Sterilizer, Boiling Water (Class I - General Controls, product code ECG).

Submitted by Preat Corp. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1981, 33 days after receiving the submission on April 10, 1981.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6710.

Submission Details

510(k) Number	K810977 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 10, 1981
Decision Date	May 13, 1981
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—