Product code NRD

Device name

Unit, Operative Dental, Accessories

Medical specialty

Dental

Device class

1

Regulation number

872.6640

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset