Acrylic Herbst Appliance with Micro-Recorder— 510(k) K170606

Name: FDA 510(k) clearance K170606
Creator: U.S. Food and Drug Administration
Published: 2017-11-16

Substantially Equivalent

Gergen'S Orthodontic Lab

FDA 510(k) clearance K170606 for Acrylic Herbst Appliance with Micro-Recorder, Substantially Equivalent on 2017-11-16. Applicant: Gergen'S Orthodontic Lab. Device class: 2.

Clearance details

Applicant: Gergen'S Orthodontic Lab
Product code: Code PLC
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2017-03-01
Decision date: 2017-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLC

view all

K254304 — iNOS intraoral biosensor2026-08-25
K252765 — ProSomnus RPMO2 OSA Device (RPMO2 OSA)2026-04-06
K233497 — Rest Assure System2024-10-03
K190353 — Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac2020-04-10
K181571 — OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor2019-04-19

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