ADJUSTABLE BITE CORRECTOR— 510(k) K942492

Substantially Equivalent

Orthoplus, Inc.

FDA 510(k) clearance K942492 for ADJUSTABLE BITE CORRECTOR, Substantially Equivalent on 1994-07-13. Applicant: Orthoplus, Inc.. Device class: 1.

Clearance details

Applicant: Orthoplus, Inc.
Product code: Code ECO
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1994-05-25
Decision date: 1994-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Rosa, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ECO

K943068 — MAGNEFORCE1994-08-17
K933542 — MESIAL LOOP BAR1994-08-05
K844234 — ACTIVE VERTICAL CORRECTOR APPLIANCE1985-01-04
K843550 — ORTHOMAG MAGNETIC FORCE SYSTEM1984-12-21
K843344 — ACTIVE VERTICAL CORRECTOR ACTIVE BITE1984-12-03

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