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510(k) K183643

Clear Image Aligners by Specialty Appliance Works, Inc. — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2019
Date Received
December 26, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Aligner, Sequential
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

Other clearances by Specialty Appliance Works, Inc.

  • K083209 — ACRYLIC HERBST SPLINT APPLIANCE (January 27, 2009)
  • K071970 — CLEAR IMAGE ALIGNER (September 25, 2007)

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