510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NXVClass II

Diagnostic Light, Soft Tissue Detector

21 CFR 872.6350 / Dental
FDA source (opens on fda.gov)

NXV is the FDA product code for Diagnostic Light, Soft Tissue Detector, a class II device type, regulated under 21 CFR 872.6350. FDA's definition for this code reads: "To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities". As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NXV
Device name
Diagnostic Light, Soft Tissue Detector
FDA definition
To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities
Regulation
21 CFR 872.6350
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
12
Ingested recalls
0

Clearances, product code NXV

By decision year
12 clearances under product code NXV with a decision year between 2006 and 2015, 2008 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code NXV by decision year
YearClearances
20061
20071
20083
20092
20102
20121
20131
20151

Applicants with the most clearances

Product code NXV
Applicants holding the most 510(k) clearances under product code NXV
ApplicantClearances
Addent, Inc.2
LED Dental Inc.2
Remicalm, LLC2
Den-Mat Holdings, LLC1
Dentlight Inc.1
Forward Science, LLC1
Led Medical Diagnostics, Inc.1
Pierrel Pharma S.r.l.1
Zila, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code