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FDA 510(k)

Acrylic Herbst Appliance with Micro-Recorder

K-Number: K170606 · 2017-11-16

ApplicantGergen'S Orthodontic Lab
Decision Date2017-11-16
Product CodePLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Acrylic Herbst Appliance with Micro-Recorder is a medical device manufactured by Gergen'S Orthodontic Lab. It received FDA 510(k) clearance on 2017-11-16 under approval number K170606. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acrylic Herbst Appliance with Micro-Recorder?

Acrylic Herbst Appliance with Micro-Recorder is a medical device that received FDA 510(k) clearance on 2017-11-16. It is manufactured by Gergen'S Orthodontic Lab. The 510(k) number is K170606.

When was Acrylic Herbst Appliance with Micro-Recorder approved by the FDA?

Acrylic Herbst Appliance with Micro-Recorder received FDA 510(k) clearance on 2017-11-16, under approval number K170606.

What company makes Acrylic Herbst Appliance with Micro-Recorder?

Acrylic Herbst Appliance with Micro-Recorder is manufactured by Gergen'S Orthodontic Lab.

What is the FDA product code for Acrylic Herbst Appliance with Micro-Recorder?

The FDA product code for Acrylic Herbst Appliance with Micro-Recorder is PLC.

Related Clinical Trials

NCT04092660 Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea. RECRUITING

Related Devices (Code: PLC)

K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. K160239TAP 3, TAP 1Airway Management, Inc. K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorderProsomnous Sleep Technologies K181571OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorMark Abramson, D.D.S., Inc. K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services K233497Rest Assure SystemSomnomed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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