simplyFixed Legacy™ Angled 8035-64-15SK

GUDID 10841307117780

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307117780
• NIH Device Record Key: 10fd03e4-ffad-4ba2-8aec-1f52ad15a183
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: simplyFixed Legacy™ Angled
• Version Model Number: 8035-64-15SK
• Catalog Number: 8035-64-15SK
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC
• Device Count: 1
• DM Exempt: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307117780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130572

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[10841307117780]

Moist Heat or Steam Sterilization

[10841307117780]

Moist Heat or Steam Sterilization

[10841307117780]

Moist Heat or Steam Sterilization

[10841307117780]

Moist Heat or Steam Sterilization

[10841307117780]

Moist Heat or Steam Sterilization

[10841307117780]

Moist Heat or Steam Sterilization

[10841307117780]

Moist Heat or Steam Sterilization

[10841307117780]

Moist Heat or Steam Sterilization

[10841307117780]

Moist Heat or Steam Sterilization

[10841307117780]

Moist Heat or Steam Sterilization

[10841307117780]

Moist Heat or Steam Sterilization

[10841307117780]

Moist Heat or Steam Sterilization

[10841307117780]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-10-02

On-Brand Devices [simplyFixed Legacy™ Angled]

• 10841307117865: 8045-64-30SK
• 10841307117858: 8045-63-30SK
• 10841307117841: 8045-64-15SK
• 10841307117834: 8045-62-15SK
• 10841307117803: 8035-64-30SK
• 10841307117797: 8035-63-30SK
• 10841307117780: 8035-64-15SK
• 10841307117773: 8035-62-15SK
• 10841307117742: 8530-63-30SK
• 10841307117735: 8530-63-15SK
• 10841307117728: 8530-62-15SK