SL3® ZLR2009

GUDID D813ZLR20090

SL3 REPLACEMENT POWER SUPPLY

DEN-MAT HOLDINGS, LLC

Dental diode laser system
Primary Device IDD813ZLR20090
NIH Device Record Keyc191ca77-c34e-4af1-9d36-993b75dd3699
Commercial Distribution StatusIn Commercial Distribution
Brand NameSL3®
Version Model NumberZLR2009
Catalog NumberZLR2009
Company DUNS809857704
Company NameDEN-MAT HOLDINGS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
HIBCCD813ZLR20090 [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 Date2022-09-30
Device Publish Date2022-09-22

On-Brand Devices [SL3®]

D813ZLR2006A1SL3 DISP PERIO TIPS 7MM 25PK
D813ZLR2005A1SL3 DISP REG TIPS 5MM 25PK
D813ZLR20040SL3 FOOT PEDAL
D813ZLR20090SL3 REPLACEMENT POWER SUPPLY
D813ZLR20080SL3 HANDPIECE AUTOCLAVABLE
D813ZLR20030SL3 UNIFIBER SYSTEM
D813ZLR10180FIBERS AC-FIBER 400um 12FT

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.