Cleared Traditional

K980245 - NITOM LOCKING FACEBOW
(FDA 510(k) Clearance)

K980245 · Ortho Kinetics Corp. · Dental

Apr 1998

Decision

88d

Days

Class 2

Risk

K980245 is an FDA 510(k) clearance for the NITOM LOCKING FACEBOW, a Headgear, Extraoral, Orthodontic (Class II — Special Controls, product code DZB), submitted by Ortho Kinetics Corp. (Vista, US). The FDA issued a Cleared decision on April 21, 1998, 88 days after receiving the submission on January 23, 1998. This device falls under the Dental review panel. Regulated under 21 CFR 872.5500.

Submission Details

510(k) Number	K980245 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 1998
Decision Date	April 21, 1998
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement