Cleared Traditional

K003995 - SPECULITE/ORALLITE
(FDA 510(k) Clearance)

K003995 · Trylon Corp. · Dental device

Mar 2001

Decision

80d

Days

Class 1

Risk

K003995 is an FDA 510(k) clearance for the SPECULITE/ORALLITE. This device is classified as a Light, Operating, Dental (Class I - General Controls, product code EAZ).

Submitted by Trylon Corp. (Torrance, US). The FDA issued a Cleared decision on March 16, 2001, 80 days after receiving the submission on December 26, 2000.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4630.

Submission Details

510(k) Number	K003995 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 26, 2000
Decision Date	March 16, 2001
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF