MYSTIQUE® MB K110-531-11

GUDID D807K110531111

MYSTIQUE® MB RT RX 018 U 5-5/L3-3 CS-BC HK

GAC

Orthodontic bracket, ceramic

• Primary Device ID: D807K110531111
• NIH Device Record Key: f633aaec-f737-42cc-9efa-c5febffa44c1
• Commercial Distribution Discontinuation: 2020-01-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MYSTIQUE® MB
• Version Model Number: K110-531-11
• Catalog Number: K110-531-11
• Company DUNS: 053475903
• Company Name: GAC
• Device Count: 16
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(631)357-8600
• Email: CustomerService_GAC@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D807K110531110 [Unit of Use]
HIBCC	D807K110531111 [Primary]

FDA Product Code

• NJM: Bracket, ceramic, orthodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-31
• Device Publish Date: 2017-06-26

On-Brand Devices [MYSTIQUE® MB]

• D807K110532101: MYSTIQUE® MB RT RX 022 U 5-5/L3-3 CS HK
• D807K110531111: MYSTIQUE® MB RT RX 018 U 5-5/L3-3 CS-BC HK
• D807K110531101: MYSTIQUE® MB RT RX 018 U5-5/L3-3 CS HK
• D807K110152101: MYSTIQUE® MB RT RX 022 U 5-5 CS HK
• D807K110151101: MYSTIQUE® MB RT RX 018 U 5-5 CS HK