Cleared Traditional

K901919 - CONTACT MOLAR BANDS AND CONTOUR STRIPS
(FDA 510(k) Clearance)

K901919 · Ivoclar North America, Inc. · Dental device

Jun 1990

Decision

57d

Days

Class 1

Risk

K901919 is an FDA 510(k) clearance for the CONTACT MOLAR BANDS AND CONTOUR STRIPS. This device is classified as a Instruments, Dental Hand (Class I - General Controls, product code DZN).

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on June 22, 1990, 57 days after receiving the submission on April 26, 1990.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K901919 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 26, 1990
Decision Date	June 22, 1990
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—