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510(k) K231722

SmarTooth by Smartooth Co., Ltd. — Product Code NBL

K231722 is an FDA 510(k) premarket notification submitted by Smartooth Co., Ltd. for the device "SmarTooth". The FDA issued a decision of Substantially Equivalent on May 1, 2024. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2024
Date Received
June 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light-Induced Fluorescence Caries Detector
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type

Other clearances for product code NBL

  • K252464 — Surgical Microscope (OMS2360, OMS2380) (April 28, 2026)
  • K242103 — TRIOS Ready Tip (April 4, 2025)
  • K221275 — Qraycam PRO (September 4, 2024)
  • K223470 — C50 (December 14, 2023)
  • K221249 — L1P-1F (TRIOS 5) (September 16, 2022)
  • K183471 — IC-WHCD100 (Inspire) (July 2, 2020)
  • K171007 — Fluorescence Mode (May 3, 2018)
  • K170822 — Electronic Caries Detector (September 11, 2017)
  • K150672 — VistaCam iX Proof (January 27, 2016)
  • K121685 — SOPROCARE (March 12, 2013)

FDA data resources