DENTAL ARCH BAR— 510(k) K820944

Substantially Equivalent

Unisplint Corp.

FDA 510(k) clearance K820944 for DENTAL ARCH BAR, Substantially Equivalent on 1982-05-05. Applicant: Unisplint Corp.. Device class: 2.

Clearance details

Applicant: Unisplint Corp.
Product code: Code DYX
Device class: Class 2
Regulation: 21 CFR 872.4600
Advisory panel: Dental
Date received: 1982-04-06
Decision date: 1982-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYX

K162046 — MINNE TIES MMF Suture System2017-04-11
K061271 — ERCH ARCH BAR, MODEL 38-690-002006-06-30
K031207 — SAFETY RELEASE ARCH BAR KIT2003-07-15
K030605 — RAPID IMF2003-06-27
K990212 — LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-001999-09-14

More clearances from Unisplint Corp.

K830675 — ORAL SPONGE1983-03-24

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