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510(k) K181571

OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor by Mark Abramson, D.D.S., Inc. — Product Code PLC

K181571 is an FDA 510(k) premarket notification submitted by Mark Abramson, D.D.S., Inc. for the device "OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor". The FDA issued a decision of Substantially Equivalent on April 19, 2019. The device falls under product code PLC (Sleep Appliances With Patient Monitoring), a Class II device regulated under 21 CFR 872.5570. Mark Abramson, D.D.S., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2019
Date Received
June 14, 2018
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 by Mark Abramson, D.D.S., Inc.

  • K030440 — OASYS-ORAL AIRWAY SYSTEM (August 26, 2003)

Other clearances for product code PLC

  • K252765 — ProSomnus RPMO2 OSA Device (RPMO2 OSA) (April 6, 2026)
  • K233497 — Rest Assure System (October 3, 2024)
  • K190353 — Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac (April 10, 2020)
  • K172859 — Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device (November 22, 2017)
  • K170606 — Acrylic Herbst Appliance with Micro-Recorder (November 16, 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