ScrewPlant® GPS® Abutment 1037-91

GUDID 10841307114550

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307114550
• NIH Device Record Key: 5d5c0f9a-e15d-4b81-97f5-7bb2306918ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScrewPlant® GPS® Abutment
• Version Model Number: 1037-91
• Catalog Number: 1037-91
• 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	10841307114550 [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

[10841307114550]

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 [ScrewPlant® GPS® Abutment]

• 10841307114680: 1057-95
• 10841307114673: 1057-94
• 10841307114666: 1057-93
• 10841307114659: 1057-92
• 10841307114642: 1047-95
• 10841307114635: 1047-94
• 10841307114628: 1047-93
• 10841307114611: 1047-92
• 10841307114604: 1047-91
• 10841307114598: 1037-95
• 10841307114581: 1037-94
• 10841307114574: 1037-93
• 10841307114567: 1037-92
• 10841307114550: 1037-91