510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NRDClass I

Unit, Operative Dental, Accessories

21 CFR 872.6640 / Dental
FDA source (opens on fda.gov)

NRD is the FDA product code for Unit, Operative Dental, Accessories, a class I device type, regulated under 21 CFR 872.6640. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NRD
Device name
Unit, Operative Dental, Accessories
FDA 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.
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code NRD

By decision year
2 clearances under product code NRD with a decision year between 2004 and 2007, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NRD by decision year
YearClearances
20041
20071

Applicants with the most clearances

Product code NRD
Applicants holding the most 510(k) clearances under product code NRD
ApplicantClearances
Air Techniques, Inc.1
Takara Belmont USA, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 145 companies shown, in name order