ORTHODONTIC ELASTOMERIC TUBE/THREAD— 510(k) K943417

Name: FDA 510(k) clearance K943417
Creator: U.S. Food and Drug Administration
Published: 1995-05-23

Substantially Equivalent

Jon-Ko Products, Inc.

FDA 510(k) clearance K943417 for ORTHODONTIC ELASTOMERIC TUBE/THREAD, Substantially Equivalent on 1995-05-23. Applicant: Jon-Ko Products, Inc.. Device class: 1.

Clearance details

Applicant: Jon-Ko Products, Inc.
Product code: Code ECI
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1994-07-15
Decision date: 1995-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ECI

view all

K980864 — POWER COINS GLOW IN THE DARK LIGATURES1998-04-20
K980053 — GLENROE CHAIN1998-02-24
K973495 — GLENROE GLOW IN DARK ELASTOMERIC LIGATURES1997-12-01
K943419 — ORTHODONTIC ELASTOMERIC LAGATURE MODULE1995-05-24
K943418 — ORTHODONTIC ELASTOMERIC SEPARATOR MODULE1995-05-23

More clearances from Jon-Ko Products, Inc.

view all

K943420 — ORTHODONTIC ELASTOMERIC CHAIN1995-05-23
K943421 — ORTHODONITC ELASTOMERIC SLEEVING1995-05-23

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