OVATION® K82-055-24

GUDID D807K82055241

OVATION® Base Rx 022 UL/5-5 CS-BC MHK

DENTSPLY SIRONA ORTHODONTICS INC.

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• Primary Device ID: D807K82055241
• NIH Device Record Key: 95d8b4f8-7e06-48f7-b3d9-b09b126e947c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OVATION®
• Version Model Number: K82-055-24
• Catalog Number: K82-055-24
• Company DUNS: 116903307
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Device Count: 20
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com
• Phone: +1(833)372-8255
• Email: CustomerService_GAC@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D807K82055240 [Unit of Use]
HIBCC	D807K82055241 [Primary]

FDA Product Code

• EJF: BRACKET, METAL, 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: 2
• Public Version Date: 2020-02-10
• Device Publish Date: 2019-09-30

On-Brand Devices [OVATION®]

• D807K82055261: OVATION® Base Rx SP 022 UL/5-5 CS-BC DHK
• D807K82055241: OVATION® Base Rx 022 UL/5-5 CS-BC MHK
• D807K82055221: OVATION® Base Rx 022 UL/5-5 CS-BC DHK
• D80783452101: OVATION® Base Rx 022/LL5 -22T-1A 4DHK
• D80783452001: OVATION® Base Rx 022/LL5 -22T-1A 4D
• D80783442101: OVATION® Base Rx 022/LL4 -17T-1A 4DHK
• D80783442001: OVATION® Base Rx 022/LL4 -17T-1A 4D
• D80783352101: OVATION® Base Rx 022/LR5 -22T-1A 4DHK
• D80783352001: OVATION® Base Rx 022/LR5 -22T-1A 4D
• D80783342101: OVATION® Base Rx 022/LR4 -17T-1A 4DHK
• D80783342001: OVATION® Base Rx 022/LR4 -17T-1A 4D
• D80783242901: OVATION® Base Rx 022/UL4 -7T 0A 2D MSHK
• D80783242101: OVATION® Base Rx 022/UL4 -7T 2D HK
• D80783242001: OVATION® Base Rx 022/UL4&5 -7T 0A 2D
• D80783241101: OVATION® Base Rx 018/UL4 -7T 2D HK
• D80783142901: OVATION® Base Rx 022/UR4 -7T 0A 2D MSHK
• D80783142101: OVATION® Base Rx 022/UR4 -7T 2D HK
• D80783142001: OVATION® Base Rx 022/UR4&5 -7T 0A 2D
• D80783141901: OVATION® Base Rx 018/UR4 -7T 0A 2D MSHK
• D80783141101: OVATION® Base Rx 018/UR4 -7T 2D HK
• D80783141001: OVATION® Base Rx 018/UR4&5 -7T 0A 2D
• D80782452101: Ovation® Base Rx022/LL5 -22T-1A4D HK
• D80782452001: Ovation® Base Rx022/LL5 -22T-1A4D
• D80782451121: Ovation® Base Rx018/LL5 -22T-1A4D XOB HK
• D80782451101: Ovation® Base Rx018/LL5 -22T-1A4D HK
• D80782451001: Ovation® Base Rx018/LL5 -22T-1A4D
• D80782442101: Ovation® Base Rx022/LL4 -17T-1A4D HK
• D80782442001: Ovation® Base Rx022/LL4 -17T-1A4D
• D80782441121: Ovation® Base Rx018/LL4 -17T-1A4D XOB HK
• D80782441101: Ovation® Base Rx018/LL4 -17T-1A4D HK
• D80782441001: Ovation® Base Rx018/LL4 -17T-1A4D
• D80782432111: Ovation® Base Rx XT022/LL3 0T 5A PST
• D80782432101: Ovation® Base Rx022/LL3 -11T7A2MHK
• D80782432001: Ovation® Base Rx022/LL3 -11T7A 2M
• D80782431111: Ovation® Base Rx XT018/LL3 0T 5A PST
• D80782431101: Ovation® Base Rx018/LL3 -11T7A2MHK
• D80782431001: Ovation® Base Rx018/LL3 -11T7A 2M
• D80782412001: Ovation® Base Rx022/LL1-2 -1T 2A
• D80782411001: Ovation® Base Rx018/LL1-2 -1T 2A
• D80782352101: Ovation® Base Rx022/LR5 -22T-1A4D HK
• D80782352001: Ovation® Base Rx022/LR5 -22T-1A4D
• D80782351121: Ovation® Base Rx018/LR5 -22T-1A4D XOB HK
• D80782351101: Ovation® Base Rx018/LR5 -22T-1A4D HK
• D80782351001: Ovation® Base Rx018/LR5 -22T-1A4D
• D80782342101: Ovation® Base Rx022/LR4 -17T-1A4D HK
• D80782342001: Ovation® Base Rx022/LR4 -17T-1A4D
• D80782341121: Ovation® Base Rx018/LR4 -17T-1A4D XOB HK
• D80782341101: Ovation® Base Rx018/LR4 -17T-1A4D HK
• D80782341001: Ovation® Base Rx018/LR4 -17T-1A4D
• D80782332101: Ovation® Base Rx022/LR3 -11T7A2MHK