Cleared Traditional

K001108 - PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
(FDA 510(k) Clearance)

K001108 · Prime Dental Manufacturing, Inc. · Dental device

May 2000

Decision

55d

Days

Class 2

Risk

K001108 is an FDA 510(k) clearance for the PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Prime Dental Manufacturing, Inc. (Chicago, US). The FDA issued a Cleared decision on May 30, 2000, 55 days after receiving the submission on April 5, 2000.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K001108 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 05, 2000
Decision Date	May 30, 2000
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement