510(k) K151630
- Device
- G.o.c.c.l.e.s.
- Applicant
- PIERREL PHARMA S.R.L.
- 510(k) number
- K151630
- Product code
- NXV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-09-15
- Date received
- 2015-06-17
- Regulation
- 872.6350
- Classification name
- Diagnostic Light, Soft Tissue Detector
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- FABIO VELOTTI
- Address
- Strada Statale Appia 46/48 Capua IT 81043 81043
FDA Registration Numbers#
- 3006999064
- 3003694926
- 3005374252
- 3010143501
- 2018957
- 3005515469
Source Documents#
Other 510(k) Records For Product Code NXV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123169 | ORALID | Forward Science, LLC | 2013-03-13 |
| K121282 | MICROLUX/DL MICROLUX/BLU BIO/SCREEN | Addent, Inc. | 2012-07-24 |
| K102083 | VELSCOPE VX | Led Dental, Inc. | 2010-11-18 |
| K101140 | DENTLIGHT ORAL EXAM LIGHT KIT | Dentlight, Inc. | 2010-07-15 |
| K090135 | TRIMIRA IDENTAFI 3000 | Remicalm, LLC | 2009-02-17 |
| K082668 | BIO-SCREEN | Addent, Inc. | 2009-01-23 |
| K082603 | TRIMIRA OCS 3000 | Remicalm, LLC | 2008-12-12 |
| K080043 | VIZILITE EYEWEAR | Zila, Inc. | 2008-04-04 |
| K073483 | SAPPHIRE O/E ORAL EXAMINATION SYSTEM | Den-Mat Holdings, LLC | 2008-04-03 |
| K070523 | MODIFICATION TO: VELSCOPE | Led Dental, Inc. | 2007-04-05 |
| K060920 | VELSCOPE | Led Medical Diagnostics, Inc. | 2006-04-27 |
Legacy Summary#
summary
FDA Review#
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