Diagnostic Light, Soft Tissue Detector
The Diagnostic Light, Soft Tissue Detector (product code NXV) is a dental diagnostic device that uses light to aid in the detection or visualization of abnormalities of intraoral soft tissue, serving as an adjunct to traditional intraoral examination by incandescent light to enhance visualization of oral mucosal abnormalities. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 872.6350 within the Dental specialty. Third-party 510(k) review is available for this device type.
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Basic Information
- Product Code
- NXV
- Device Class
- FDA class 2
- Regulation Number
- 872.6350
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K151630 | G.o.c.c.l.e.s. | Sep 15, 2015 | Substantially Equivalent | Pierrel Pharma S.R.L. |
| K123169 | ORALID | Mar 13, 2013 | Substantially Equivalent | Forward Science, LLC |
| K121282 | MICROLUX/DL MICROLUX/BLU BIO/SCREEN | Jul 24, 2012 | Substantially Equivalent | Addent, Inc. |
| K102083 | VELSCOPE VX | Nov 18, 2010 | Substantially Equivalent | Led Dental, Inc. |
| K101140 | DENTLIGHT ORAL EXAM LIGHT KIT | Jul 15, 2010 | Substantially Equivalent | Dentlight, Inc. |
| K090135 | TRIMIRA IDENTAFI 3000 | Feb 17, 2009 | Substantially Equivalent | Remicalm, LLC |
| K082668 | BIO-SCREEN | Jan 23, 2009 | Substantially Equivalent | Addent, Inc. |
| K082603 | TRIMIRA OCS 3000 | Dec 12, 2008 | Substantially Equivalent | Remicalm, LLC |
| K080043 | VIZILITE EYEWEAR | Apr 04, 2008 | Substantially Equivalent | Zila, Inc. |
| K073483 | SAPPHIRE O/E ORAL EXAMINATION SYSTEM | Apr 03, 2008 | Substantially Equivalent | Den-Mat Holdings, LLC |
| K070523 | MODIFICATION TO: VELSCOPE | Apr 05, 2007 | Substantially Equivalent | Led Dental, Inc. |
| K060920 | VELSCOPE | Apr 27, 2006 | Substantially Equivalent | Led Medical Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.