Cleared Traditional

K892373 - DENTAL PLASTIC BITE FORK (FDA 510(k) Clearance)

K892373 · Texapol Corp. · Dental device

Jun 1989

Decision

67d

Days

Class 1

Risk

K892373 is an FDA 510(k) clearance for the DENTAL PLASTIC BITE FORK. This device is classified as a Articulators (Class I - General Controls, product code EJP).

Submitted by Texapol Corp. (Bethlehem, US). The FDA issued a Cleared decision on June 12, 1989, 67 days after receiving the submission on April 6, 1989.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3150.

Submission Details

510(k) Number	K892373 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 06, 1989
Decision Date	June 12, 1989
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—