FDA product code NXV: Diagnostic Light, Soft Tissue Detector
NXV is the FDA product code for diagnostic light, soft tissue detector. It is a Class II device, regulated under 21 CFR 872.6350 and reviewed by the Dental panel. FDA has cleared 12 510(k) submissions under NXV, from 9 different applicants. The average 510(k) review took 87 days (median 88).
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
Classification
| Field | Value |
|---|---|
| Device name | Diagnostic Light, Soft Tissue Detector |
| Device class | Class II |
| Regulation | 21 CFR 872.6350 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NXV clearance
Top NXV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Addent, Inc. | 2 | 2012-07-24 |
| Led Dental, Inc. | 2 | 2010-11-18 |
| Remicalm, LLC | 2 | 2009-02-17 |
| Pierrel Pharma S.R.L. | 1 | 2015-09-15 |
| Forward Science, LLC | 1 | 2013-03-13 |
4 more applicants have NXV clearances. See the full list in Caduvo.
Most recent NXV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151630 | Pierrel Pharma S.R.L. | G.o.c.c.l.e.s. | 2015-09-15 | 90 |
| K123169 | Forward Science, LLC | ORALID | 2013-03-13 | 155 |
| K121282 | Addent, Inc. | MICROLUX/DL MICROLUX/BLU BIO/SCREEN | 2012-07-24 | 85 |
| K102083 | Led Dental, Inc. | VELSCOPE VX | 2010-11-18 | 115 |
| K101140 | Dentlight, Inc. | DENTLIGHT ORAL EXAM LIGHT KIT | 2010-07-15 | 84 |
Recalls for NXV devices
openFDA lists no recalls for product code NXV.
Frequently asked questions
What is FDA product code NXV?
NXV is the FDA product code for diagnostic light, soft tissue detector. It is a Class II device, regulated under 21 CFR 872.6350 and reviewed by the Dental panel.
What device class is NXV?
Class II, regulation 21 CFR 872.6350. Typical premarket route: 510(k).
How long does a 510(k) take for product code NXV?
Across 12 cleared submissions the average was 87 days from receipt to decision (median 88).
Which companies have the most NXV clearances?
Addent, Inc. (2); Led Dental, Inc. (2); Remicalm, LLC (2); Pierrel Pharma S.R.L. (1); Forward Science, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NXV
- Run a recall and safety report across every NXV manufacturer
- Watch product code NXV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times