Legacy™ GPS® Abutment 8530-91

GUDID 10841307111252

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307111252
• NIH Device Record Key: 590b9aae-72a1-4bae-84a6-f963a0f10528
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Legacy™ GPS® Abutment
• Version Model Number: 8530-91
• Catalog Number: 8530-91
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307111252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143011

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[10841307111252]

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: 2015-09-14

On-Brand Devices [Legacy™ GPS® Abutment]

• 10841307111290: 8530-95
• 10841307111283: 8530-94
• 10841307111276: 8530-93
• 10841307111269: 8530-92
• 10841307111252: 8530-91
• 10841307111245: 8057-95
• 10841307111238: 8057-94
• 10841307111221: 8057-93
• 10841307111214: 8057-92
• 10841307111207: 8057-91
• 10841307111191: 8045-95
• 10841307111184: 8045-94
• 10841307111177: 8045-93
• 10841307111160: 8045-92
• 10841307111153: 8045-91
• 10841307111146: 8045-90
• 10841307111139: 8035-95
• 10841307111122: 8035-94
• 10841307111115: 8035-93
• 10841307111108: 8035-92
• 10841307111092: 8035-91
• 10841307111085: 8035-90