Essix A+ 10065-SH

GUDID D74610065SH1

Essix A+ Plastic .060 x 5" Square 20PK

RAINTREE ESSIX INC.

Dental implant template, radiographic

• Primary Device ID: D74610065SH1
• NIH Device Record Key: ef5f28be-a9a5-4e76-863a-95b338a22712
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Essix A+
• Version Model Number: 10065-SH
• Catalog Number: 10065-SH
• Company DUNS: 801157132
• Company Name: RAINTREE ESSIX INC.
• Device Count: 20
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D74610065SH0 [Unit of Use]
HIBCC	D74610065SH1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062828

FDA Product Code

• MQC: Mouthguard, prescription

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-09-24

On-Brand Devices [Essix A+]

• D746135001: Essix A+ plastic .120mm x 5" Square 25/PK
• D746115451: Essix A+ Plastic- .040in 135mm CIR
• D746110811: Essix A+ .080 x 120mm Circle 50/PK
• D74611080251: Essix A+ Plastic .080 x 125mm Cir For Sale 25Pk
• D746110801: Essix A+ Plastic .080 x 125mm PETG Vacuum Circles 50PK
• D746110611: Essix A+ Plastic .060 x 120mm Circles 50PK
• D746110601: Essix A+ Plastic .060 x 125mm PETG Vacuum Circles 50PK
• D746110411: Essix A+ Plastic .040 x 120mm Circle 100PK
• D74611040SH1: Essix A+ .040 x 125mm Circle 20PK
• D746110401: Essix A+ .040 x 125mm Circle (100PK)
• D746110311: Essix A+ Plastic .030 x 120mm PETG Vacuum Circles 100PK
• D74611030SH1: Essix A+ Plastic .030 x 125mm Circle 20PK
• D746110301: Essix A+ Plastic .030 x 125mm Circle 100PK
• D746110211: Essix A+ plastic .020 x 120mm circle 100PK
• D74611020SH1: Essix A+ Plastic .020 x 125mm circle 20PK
• D746110201: Essix A+ Plastic .020 x 125mm circle 100PK
• D746100851: Essix A+ Plastic .080 x 5" Square 50PK
• D746100801: Essix A+ Plastic .080 x 125 For Sale 50Pk
• D74610065SH1: Essix A+ Plastic .060 x 5" Square 20PK
• D74610065251: Essix A+ Plastic .060 x 5" Square 25 PK
• D746100651: Essix A+ Plastic .060 x 5" Square 50PK
• D746100601: Essix A+ Plastic .060 x 4.92" Square 50 PK
• D74610045SH1: Essix A+ Plastic .040 x 5" PETG Vacuum Square 20PK
• D74610045501: Essix A+ Plastic .040 x 5" PETG Vacuum Square 50Pk
• D746100451: Essix A+ Plastic .040 x 5" PETG Vacuum Square 100PK
• D746100401: Essix A+ plastic .040 x 4.92" square 100PK
• D74610035SH1: Essix A+ Plastic .030 x 5" PETG Vacuum Square 20PK
• D74610035501: Essix A+ Plastic .030 x 5" PETG Vacuum Square 50PK
• D746100351: Essix A+ Plastic .030 x 5" PETG Vacuum Square 100PK
• D746100301: Essix A+ Plastic .030 x 4.92" Square 100/PK
• D74610025SH1: Essix A+ .020 x 5" square 20PK
• D74610025501: Essix A+ .020 x 5" square 50PK
• D746100251: Essix A+ .020 x 5" square 100PK
• D746100201: Essix A+ Plastic .020 x 4.92"' Square 100PK