SOL® LR1001WINT

GUDID D813LR1001WINT0

SOL INTEGRATED WIRLESS IT

DEN-MAT HOLDINGS, LLC

Dental diode laser system
Primary Device IDD813LR1001WINT0
NIH Device Record Keyf00b9dc8-9dd4-4aab-821b-12d22fc1e807
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOL®
Version Model NumberLR1001WINT
Catalog NumberLR1001WINT
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

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
Phone18004336628
Emailinfo@denmat.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD813LR1001WINT0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-09-30
Device Publish Date2022-09-22

On-Brand Devices [SOL®]

D813LR10450KT SOL WIRELESS UPGRADE
D813LR10101SOL/SAPH ASSY 300um TIP 25pc
D813LR10040SOL FOOT PEDAL ASSY
D813LR1001WL0SOL WIRELESS LOANER
D813LR1001W0SOL LASER SYSTEM INTG WIRELESS
D813LR1001L0SOL LASER SYSTEM INTG LOANER
D813LR1001DW0SOL LASER INTG WIRELESS-DEALER
D813LR100060SOL HANDPIECE REPLACEMENT KIT
D81303398002801SOL/SAPH LSR 400um TIPS 25pc
D813LR1008CCD0CC LASER SAFETY GLASSES
D813LR10080LASER EYEWEAR
D813LR1001WINT0SOL INTEGRATED WIRLESS IT

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