Black 3mm M.G. 120mm 1M120C-BK

GUDID D7461M120CBK1

Black 3mm M.G. 120mm Circle

RAINTREE ESSIX INC.

Dental implant template, radiographic Dental implant x-ray template Dental implant x-ray template Dental implant x-ray template Dental implant x-ray template Dental implant x-ray template Dental implant x-ray template Dental implant x-ray template Dental implant x-ray template Dental implant x-ray template Dental implant x-ray template Dental implant x-ray template Dental implant x-ray template Dental implant x-ray template

• Primary Device ID: D7461M120CBK1
• NIH Device Record Key: 80c1c454-4caf-4a06-9931-3f3f2953b33f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Black 3mm M.G. 120mm
• Version Model Number: 1M120C-BK
• Catalog Number: 1M120C-BK
• Company DUNS: 801157132
• Company Name: RAINTREE ESSIX INC.
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7461M120CBK1 [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

Devices Manufactured by RAINTREE ESSIX INC.

• D74627310701 - VISTADENT® OC: 2021-12-17 VISTADENT® OC CONSULTANT
• D7462731070U1 - VISTADENT® OC: 2021-12-17 VISTADENT® OC CONSULTANT UPDATE
• D74627310991 - VISTADENT® OC: 2021-12-17 VISTADENT® OC COMPLETE
• D7462731099U1 - VISTADENT® OC: 2021-12-17 VISTADENT® OC COMPLETE UPDATE
• D7462731170L1 - VISTADENT® OC: 2021-12-17 VISTADENT® OC CONSULTANT (LATIN AM)
• D7462731199L1 - VISTADENT® OC: 2021-12-17 VISTADENT® OC COMPLETE LATIN AMERICA
• D74627313991 - VISTADENT® OC: 2021-12-17 VISTADENT® OC SUBSCRIPTION EAST
• D74627314991 - VISTADENT® OC: 2021-12-17 VISTADENT® OC SUBSCRIPTION LAT AMERICA