FACEBOW— 510(k) K980195

Substantially Equivalent

Ortho Kinetics Corp.

FDA 510(k) clearance K980195 for FACEBOW, Substantially Equivalent on 1998-03-11. Applicant: Ortho Kinetics Corp.. Device class: 2.

Clearance details

Applicant: Ortho Kinetics Corp.
Product code: Code DZB
Device class: Class 2
Regulation: 21 CFR 872.5500
Advisory panel: Dental
Date received: 1998-01-20
Decision date: 1998-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZB

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More clearances from Ortho Kinetics Corp.

K982088 — AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM1998-09-04
K980436 — CLASS III REVERSE PULL FACEMASK1998-04-27
K980245 — NITOM LOCKING FACEBOW1998-04-21
K980864 — POWER COINS GLOW IN THE DARK LIGATURES1998-04-20
K980151 — RELEASABLE FORCE MODULE1998-04-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.