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510(k) K210613

HIT Clear Aligner by Cdb Corporation — Product Code NXC

K210613 is an FDA 510(k) premarket notification submitted by Cdb Corporation for the device "HIT Clear Aligner". The FDA issued a decision of Substantially Equivalent on June 4, 2021. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470. Cdb Corporation has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2021
Date Received
March 1, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

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 Cdb Corporation

  • K212173 — HDH Treatment Planning System (January 25, 2022)
  • K191823 — Clear-Aligners (December 20, 2019)
  • K160957 — CDB Self Ligating Bracket 8F (September 27, 2016)
  • K091702 — CDB FLIP-SIDE-CLIP BRACKET (August 7, 2009)
  • K080906 — CDB CLIP (October 17, 2008)

Other clearances for product code NXC

  • K260527 — FACE4D Aligner (July 2, 2026)
  • K260788 — Smylio Aligners (May 8, 2026)
  • K260722 — SureSmile Aligner (ASSY500020) (April 15, 2026)
  • K253282 — ZSmile System (February 3, 2026)
  • K251454 — Clear Aligner (SCF-3348) (January 7, 2026)
  • K250739 — Primeprint Direct Aligner (November 7, 2025)
  • K252931 — Invisalign® Palatal Expander System (October 23, 2025)
  • K252870 — Invisalign Specifix Attachment System (October 9, 2025)
  • K251758 — Serafin® (September 11, 2025)
  • K252380 — Invisalign System (August 29, 2025)

FDA data resources