Cleared Traditional

K780814 - SAFETY STOP NECKSTRAP
(FDA 510(k) Clearance)

K780814 · Northwest Orthodontics, Inc. · Dental device

Jun 1978

Decision

43d

Days

Class 1

Risk

K780814 is an FDA 510(k) clearance for the SAFETY STOP NECKSTRAP. This device is classified as a Maintainer, Space Preformed, Orthodontic (Class I - General Controls, product code DYT).

Submitted by Northwest Orthodontics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1978, 43 days after receiving the submission on May 18, 1978.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5525.

Submission Details

510(k) Number	K780814 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 18, 1978
Decision Date	June 30, 1978
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—