NV PRO3 ZLR3003INT

GUDID D813ZLR3003INT0

NV PRO3 MICROLASER IT

DEN-MAT HOLDINGS, LLC

Dental diode laser system
Primary Device IDD813ZLR3003INT0
NIH Device Record Keyd8764287-1c4b-44bf-a43c-775f9e36a51e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNV PRO3
Version Model NumberZLR3003INT
Catalog NumberZLR3003INT
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com
Phone18004336628
Emailinfo@denmat.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween 6 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD813ZLR3003INT0 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-31
Device Publish Date2024-10-23

Devices Manufactured by DEN-MAT HOLDINGS, LLC

00359883007201 - EVANESCE2025-06-09 19g MIXING TIPS 25pk
00359883005665 - Tissue Goo™ Hemostatic Gel 4-Pack2025-03-26 Gingival Retraction Solution
00359883005672 - Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit2025-03-26 Gingival Retraction Solution
00359883002046 - Affinity™ Heavy Body RS 120ml 2-Pack2025-03-24 VPS Impression Material
00359883006273 - Final Shine Cotton Polishing Wheel 50-Pack2025-03-21 Wheel, Polishing Agent
00359883006501 - Clinician's Choice® G5 Sample Pack2025-03-21 Dental coating, tooth-desensitizing, professional
00359883000608 - PowerMix™ Automatic Impression Material Dispenser2025-03-20 Two-component dental material applicator, electric
00359883000615 - PowerMix™ Dynamic Mixing Tips2025-03-20 Dental material mixing nozzle, non-sterile

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.