Pinn-Point Brushes

GUDID D68382001

Disposable PinnPoint Brushes

METREX RESEARCH, LLC

Dental material application tool, single-use
Primary Device IDD68382001
NIH Device Record Key27be0b7a-aa88-47ed-b81e-5e0a9befff7c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePinn-Point Brushes
Version Model Number8200C
Company DUNS145963778
Company NameMETREX RESEARCH, LLC
Device Count250
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+18008411428
Emailcustomercare@kavokerrgroup.com
Phone+18008411428
Emailcustomercare@kavokerrgroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100615375005262 [Primary]
GS100615375007822 [Unit of Use]
HIBCCD68382001 [Secondary]

FDA Product Code

KXRAPPLICATOR, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-08
Device Publish Date2016-08-31

Devices Manufactured by METREX RESEARCH, LLC

00615375009543 - Endeavour™ XL2025-05-08 Endeavour™ XL Headlight System - Kavo China, TTL
00615375010129 - Universal Flip - Plano2025-05-08 Universal Flip loupe with plano lenses
00615375010136 - Universal Flip - Rx2025-05-08 Universal Flip loupe with prescription lenses
00615375013533 - Endeavour™ TruColor™2025-05-08 Endeavour™ TruColor™ headlight system - North America, TTL
00615375013540 - Endeavour™ TruColor™2025-05-08 Endeavour™ TruColor™ headlight system - North America, FU1
00615375013557 - Endeavour™ TruColor™2025-05-08 Endeavour™ TruColor™ headlight system - North America, FU2
00615375013564 - Endeavour™ TruColor™2025-05-08 Endeavour™ TruColor™ headlight system - North America, GSC
00615375014493 - Dragonfly™ - Headlight only - Plano2025-05-08 Dragonfly™ frame with no oculars (headlight only) and plano lenses

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