SOL® LR1010

GUDID D813LR10101

SOL/SAPH ASSY 300um TIP 25pc

DEN-MAT HOLDINGS, LLC

Dental diode laser system
Primary Device IDD813LR10101
NIH Device Record Key110170d7-16c4-4806-900b-3889e0144567
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOL®
Version Model NumberLR1010
Catalog NumberLR1010
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Phone1-800-433-6628
Emailinfo@denmat.com
Phone1-800-433-6628
Emailinfo@denmat.com

Device Dimensions

Length400 Micrometer
Length400 Micrometer

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD813LR10100 [Unit of Use]
HIBCCD813LR10101 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-08
Device Publish Date2016-09-24

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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