Ovation® C 310-131-10

GUDID D807310131101

Ovation® C RT RX 018/UR3-2T 13A 4M HK

GAC

Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic

• Primary Device ID: D807310131101
• NIH Device Record Key: f976c83f-d369-4c18-9173-6498b781fd53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ovation® C
• Version Model Number: 310-131-10
• Catalog Number: 310-131-10
• Company DUNS: 053475903
• Company Name: GAC
• Device Count: 10
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D807310131100 [Unit of Use]
HIBCC	D807310131101 [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 [Ovation® C ]

• D807K310532111: OVATION® C RT RX 022 U5-5/L3-3 CS BC HK
• D807K310531111: OVATION® C RT RX 018 U5-5/L3-3 CS BC HK
• D807K310152111: OVATION® C RT RX 022 U5-5 CS BC HK
• D807310611001: Ovation® C Base Rx 018/L1&2 0T 0A
• D807310542101: Ovation® C RT RX 022/U4&5 -7T 0A HK
• D807310542001: Ovation® C RT RX 022/U4&5 -7T 0A
• D807310431101: Ovation® C RT RX 018/LL3 -11T 7A 2M HK
• D807310332101: Ovation® C RT RX 022/LR3 -11T 7A 2M HK
• D807310331001: Ovation® C RT RX 018/LR3 -11T 7A 2M
• D807310231161: Ovation® C RT RX SP 018/UL3-2T 9A 4M HK
• D807310231101: Ovation® C RT RX 018/UL3 -2T 13A 4M HK
• D807310231001: Ovation® C RT RX 018/UL3 -2T 13A 4M
• D807310221001: Ovation® C RT RX 018/UL2 8T 9A
• D807310132101: Ovation® C RT RX 022/UR3 -2T 13A 4M HK
• D807310132001: Ovation® C RT RX 022/UR3 -2T 13A 4M
• D807310131161: Ovation® C RT RX SP 018/UR3 -2T 9A 4M HK
• D807310131101: Ovation® C RT RX 018/UR3-2T 13A 4M HK
• D807310131001: Ovation® C RT RX 018/UR3 -2T 13A 4M
• D807310122001: Ovation® C RT RX 022/UR2 8T 9A
• D807310121001: Ovation® C RT RX 018/UR2 8T 9A
• D807310112001: Ovation® C RT RX 022/UR1 12T 5A
• D807310111001: Ovation® C RT RX 018/UR1 12T 5A