Essix + 1APL35S125

GUDID D7461APL35S1251

Essix + Plastic 80 ct .035 (7/8mm) -125mm square

RAINTREE ESSIX INC.

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• Primary Device ID: D7461APL35S1251
• NIH Device Record Key: eb869665-7a5a-4f68-9e1a-f515d23cc818
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Essix +
• Version Model Number: 1APL35S125
• Catalog Number: 1APL35S125
• Company DUNS: 801157132
• Company Name: RAINTREE ESSIX INC.
• Device Count: 80
• 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
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7461APL35S1250 [Unit of Use]
HIBCC	D7461APL35S1251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062828

FDA Product Code

• KMY: POSITIONER, TOOTH, PREFORMED

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 +]

• D7461APL40S51: Essix + Plastic 80 ct .040 (1mm) -5" Square
• D7461APL40S1251: Essix + Plastic 80 ct .040 (1mm) -125mm Square
• D7461APL40C1251: Essix + Plastic 80 ct .040 (1 mm) -125mm circle
• D7461APL40C1201: Essix + Plastic 80 ct .040 1 mm) -120mm circle
• D7461APL35S51: Essix + Plastic 80 ct .035 (7/8mm) -5" square
• D7461APL35S1251: Essix + Plastic 80 ct .035 (7/8mm) -125mm square
• D7461APL35C1251: Essix + Plastic 80 ct .035 (7/8mm) -125mm circle
• D7461APL35C1201: Essix + Plastic 80 ct .035 (7/8mm) -120mm circle