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510(k) K170606

Acrylic Herbst Appliance with Micro-Recorder by Gergen'S Orthodontic Lab — Product Code PLC

K170606 is an FDA 510(k) premarket notification submitted by Gergen'S Orthodontic Lab for the device "Acrylic Herbst Appliance with Micro-Recorder". The FDA issued a decision of Substantially Equivalent on November 16, 2017. The device falls under product code PLC (Sleep Appliances With Patient Monitoring), a Class II device regulated under 21 CFR 872.5570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2017
Date Received
March 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleep Appliances With Patient Monitoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.

Other clearances for product code PLC

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  • K233497 — Rest Assure System (October 3, 2024)
  • K190353 — Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac (April 10, 2020)
  • K181571 — OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor (April 19, 2019)
  • K172859 — Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device (November 22, 2017)
  • K161624 — MicrO2 OSA Device with Micro-Recorder (November 7, 2016)
  • K160239 — TAP 3, TAP 1 (August 10, 2016)
  • K150369 — SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac M (June 18, 2015)

FDA data resources