DEVICE: NV®PRO3 (D813ZLR3003L0)
Device Identifier (DI) Information
NV®PRO3
ZLR3003L
In Commercial Distribution
ZLR3003L
DEN-MAT HOLDINGS, LLC
ZLR3003L
In Commercial Distribution
ZLR3003L
DEN-MAT HOLDINGS, LLC
NV PRO3 MICROLASER LOANER
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60340 | Dental diode laser system |
A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEX | Powered Laser Surgical Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keey Dry |
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit |
Handling Environment Temperature: between 6 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
abc6cfa3-048e-465f-858d-5ae87d6cb5f8
October 31, 2022
5
January 05, 2017
October 31, 2022
5
January 05, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
18004336628
info@denmat.com
info@denmat.com