MINI OVATION® K85-055-24

GUDID D807K85055241

MINI OVATION® Base Rx 022 UL/5-5 CS-BC MHK

DENTSPLY SIRONA ORTHODONTICS INC.

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• Primary Device ID: D807K85055241
• NIH Device Record Key: 1d4bbff4-961d-4318-8fd0-22c9b8fbc049
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINI OVATION®
• Version Model Number: K85-055-24
• Catalog Number: K85-055-24
• 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	D807K85055240 [Unit of Use]
HIBCC	D807K85055241 [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 [MINI OVATION®]

• D807K85055241: MINI OVATION® Base Rx 022 UL/5-5 CS-BC MHK
• D807K85055231: MINI OVATION® Base Rx 022 UL/5-5 CS HK
• D80785452141: Mini Ovation® 022/LL5 -22T-1A4D HK
• D80785452101: Mini Ovation® 022/LL5-22T-1A4DXOBHK
• D80785452001: Mini Ovation® 022/LL5 -22T-1A4D XOB
• D80785451141: Mini Ovation® 018/LL5 -22T-1A4D HK
• D80785451101: Mini Ovation® 018/LL5-22T-1A4DXOBHK
• D80785451001: Mini Ovation® 018/LL5 -22T-1A4D XOB
• D80785442141: Mini Ovation® 022/LL4 -17T-1A4D HK
• D80785442101: Mini Ovation® 022/LL4-17T-1A4DXOBHK
• D80785442001: Mini Ovation® 022/LL4 -17T-1A4D XOB
• D80785441141: Mini Ovation® 018/LL4 -17T-1A4D HK
• D80785441101: Mini Ovation® 018/LL4-17T-1A4DXOBHK
• D80785441001: Mini Ovation® 018/LL4 -17T-1A4D XOB
• D80785432101: Mini Ovation® 022/LL3 -11T 7A 2M HK
• D80785432001: Mini Ovation® 022/LL3 -11T 7A 2M
• D80785431101: Mini Ovation® 018/LL3 -11T 7A 2M HK
• D80785431001: Mini Ovation® 018/LL3 -11T 7A 2M
• D80785412021: Mini Ovation® 022/LL1&2 -5T 2A
• D80785412001: Mini Ovation® 022/LL1&2 -1T 2A
• D80785411021: Mini Ovation® 018/LL1&2 -5T 2A
• D80785411001: Mini Ovation® 018/LL1&2 -1T 2A
• D80785352141: Mini Ovation® 022/LR5 -22T-1A4D HK
• D80785352101: Mini Ovation® 022/LR5-22T-1A4DXOBHK
• D80785352001: Mini Ovation® 022/LR5 -22T-1A4D XOB
• D80785351141: Mini Ovation® 018/LR5 -22T-1A4D HK
• D80785351101: Mini Ovation® 018/LR5-22T-1A4DXOBHK
• D80785351001: Mini Ovation® 018/LR5 -22T-1A4D XOB
• D80785342141: Mini Ovation® 022/LR4 -17T-1A 4D HK
• D80785342101: Mini Ovation® 022/LR4-17T-1A 4DXOBHK
• D80785342001: Mini Ovation® 022/LR4 -17T-1A 4D XOB
• D80785341141: Mini Ovation® 018/LR4 -17T-1A 4D HK
• D80785341101: Mini Ovation® 018/LR4-17T-1A 4DXOBHK
• D80785341001: Mini Ovation® 018/LR4 -17T-1A4D XOB
• D80785332101: Mini Ovation® 022/LR3 -11T 7A 2M HK
• D80785332001: Mini Ovation® 022/LR3 -11T 7A 2M
• D80785331101: Mini Ovation® 018/LR3 -11T 7A 2M HK
• D80785312021: Mini Ovation® 022/LR1&2 -5T 2A
• D80785312001: Mini Ovation® 022/LR1&2 -1T 2A
• D80785311001: Mini Ovation® 018/LR1&2 -1T 2A
• D80785242901: Mini Ovation® 022/UL4 -7T0A2D MSHK
• D80785242001: Mini Ovation® 022/UL4&5 -7T 0A 2D
• D80785241901: Mini Ovation® 018/UL4 -7T0A2D MSHK
• D80785241001: Mini Ovation® 018/UL4/5 -7T 0A 2D
• D80785232161: Mini Ovation® SP022/UL3 -2T9A4M HK
• D80785232101: Mini Ovation® 022/UL3 -2T 13A 4M HK
• D80785232001: Mini Ovation® 022/UL3 -2T 13A 4M
• D80785231161: Mini Ovation® SP018/UL3 -2T9A4M HK
• D80785231101: Mini Ovation® 018/UL3 -2T 13A 4M HK
• D80785222001: Mini Ovation® 022/UL2 8T 9A