SL3® ZLR2005A

GUDID D813ZLR2005A1

SL3 DISP REG TIPS 5MM 25PK

DEN-MAT HOLDINGS, LLC

Dental diode laser system Dental diode laser system
Primary Device IDD813ZLR2005A1
NIH Device Record Keyc575df53-f920-4810-b7db-95b229edf672
Commercial Distribution StatusIn Commercial Distribution
Brand NameSL3®
Version Model NumberZLR2005A
Catalog NumberZLR2005A
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

Length5 Millimeter
Length5 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD813ZLR2005A0 [Unit of Use]
HIBCCD813ZLR2005A1 [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 [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

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