Unit, Operative Dental, Accessories

NRD · Class I — Low Risk (general controls) · Dental · 21 CFR 872.6640

Classification

FDA Product Code: NRD
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 872.6640
Review panel: DE
Medical specialty: Dental
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 139

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown