Diagnostic Light, Soft Tissue Detector

Product Code: NXV

Dental General Optical Products / Medical

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.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 872.6350


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as NXV

1361Diagnostic Light, Soft Tissue DetectorUltraviolet Detector.

Total Product Life Cycle (TPLC) Devices

1361Diagnostic Light, Soft Tissue DetectorUltraviolet Detector.

Pre-market Notifications for NXV

K151630G.o.c.c.l.e.s.PIERREL PHARMA S.R.L.
K123169ORALIDFORWARD SCIENCE LLC
K121282MICROLUX/DL MICROLUX/BLU BIO/SCREENADDENT, INC.
K102083VELSCOPE VXLED DENTAL INC.
K101140DENTLIGHT ORAL EXAM LIGHT KITDENTLIGHT INC.
K090135TRIMIRA IDENTAFI 3000REMICALM, LLC
K082668BIO-SCREENADDENT, INC.
K082603TRIMIRA OCS 3000REMICALM, LLC
K080043VIZILITE EYEWEARZILA, INC.
K073483SAPPHIRE O/E ORAL EXAMINATION SYSTEMDEN-MAT HOLDINGS, LLC
K070523MODIFICATION TO: VELSCOPELED DENTAL INC.
K060920VELSCOPELED MEDICAL DIAGNOSTICS INC.

Global Unique Device Identification Database

00370275123163Diagnostic Light, Soft Tissue Detector
00754020100096Diagnostic Light, Soft Tissue Detector
00754020100041Diagnostic Light, Soft Tissue Detector
00754020100010Diagnostic Light, Soft Tissue Detector
07540201000094Diagnostic Light, Soft Tissue Detector
07540201000049Diagnostic Light, Soft Tissue Detector
27540201000036Diagnostic Light, Soft Tissue Detector
07540201000025Diagnostic Light, Soft Tissue Detector
07540201000018Diagnostic Light, Soft Tissue Detector
D813PLS10010Diagnostic Light, Soft Tissue Detector
D8136501010Diagnostic Light, Soft Tissue Detector
D8691120010Diagnostic Light, Soft Tissue Detector
D86911009002Diagnostic Light, Soft Tissue Detector
00860179001075Diagnostic Light, Soft Tissue Detector
D813PLS10080Diagnostic Light, Soft Tissue Detector

Maude Adverse Events

VIZILITE PRODEN-MAT HOLDINGS LLC2018-08-08
VELSCOPELED DENTAL INC2008-03-25
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