NBL · Class II · 21 CFR 872.1745

FDA Product Code NBL: Laser, Fluorescence Caries Detection

Leading manufacturers include Sopro, 3Shape TRIOS A/S and Kavo America.

Total

Cleared

276d

Avg days

2000

Since

Declining activity - 2 submissions in the last 2 years vs 3 in the prior period

Consistent review times: 263d avg (recent)

FDA 510(k) Cleared Laser, Fluorescence Caries Detection Devices (Product Code NBL)

24 devices

1–24 of 24

Cleared Apr 28, 2026

Surgical Microscope (OMS2360, OMS2380)

K252464

Zumax Medical Co., Ltd.

Good Doctors Co., Ltd.

Carl Zeiss Suzhou Co., Ltd.

Dental · 394d

Cleared Sep 11, 2017

Electronic Caries Detector

K170822

Ortek Therapeutics, Inc.

Quantum Dental Technologies, Inc.

Dental · 458d

Cleared Mar 02, 2012

CS 1600 INTRAORAL CAMERA

K111423

Carestream Health, Inc.

Therapeutic Technologies, Inc.

SPECTRA FLUORESCENCE CARIES DETECTION DEVICE

D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138

K063321

Neks Technologies, Inc.

DIAGNODENT PERIO TIP (ACCESSORY)

K042394

Kavo America Corporation

Dental · 334d

Cleared Apr 28, 2005

D-CARIE, MODEL N121-M1

K043156

Neks Technologies, Inc.

Dental · 164d

Not Cleared Feb 22, 2000

About Product Code NBL - Regulatory Context

510(k) Submission Activity

24 total 510(k) submissions under product code NBL since 2000, with 23 receiving FDA clearance (average review time: 276 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - NBL Product Code

FDA review times for NBL submissions have been consistent, averaging 263 days recently vs 277 days historically.

NBL devices are reviewed by the Dental panel. Browse all Dental devices →

FDA Product Code NBL: Laser, Fluorescence Caries Detection

FDA 510(k) Cleared Laser, Fluorescence Caries Detection Devices (Product Code NBL)

About Product Code NBL - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - NBL Product Code

Related FDA 510(k) Regulatory Insights