N/A 68011091

GUDID 07392532258619

PrimeTaper EV Ø3.6 x 9mm OsseoSpeed

Dentsply Implants Manufacturing GmbH

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 07392532258619
• NIH Device Record Key: cefa8c21-4005-4c83-9c49-5685d284122c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 68011091
• Catalog Number: 68011091
• Company DUNS: 344038836
• Company Name: Dentsply Implants Manufacturing GmbH
• 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: true
• 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(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07392532258619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210610

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-07
• Device Publish Date: 2021-08-30

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• EFRI310721032: Conometric Healing Cap, Ø4.5/6.0
• EFRI310721022: Conometric Healing Cap, Ø3.3/6.0
• EFRI310721012: Conometric Healing Cap, Ø3.3/4.8
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• 07392532258626: PrimeTaper EV Ø3.6 x 11mm OsseoSpeed
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