← FDA Medical Device Classifications

Caries Detector, Laser Light, Transmission

NTK · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.1745

Classification

FDA Product Code

NTK

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 872.1745

Review panel

DE

Medical specialty

Dental

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

11

Registered establishments

23

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown