GP Implant System SP0850

GUDID 07290018068069

Spiral Shape Implant 5.0 mm diameter by 8 mm length

GP - IMPLANT LTD

Dental implant system

• Primary Device ID: 07290018068069
• NIH Device Record Key: 5de975b7-04f0-43e4-a16e-918278318e35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GP Implant System
• Version Model Number: SP0850
• Catalog Number: SP0850
• Company DUNS: 600317167
• Company Name: GP - IMPLANT LTD
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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: +972542079520
• Email: allsystemimplant@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290018068069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162299

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: 2019-09-13
• Device Publish Date: 2019-09-05

On-Brand Devices [GP Implant System]

• 07290018068649: Cover Screw
• 07290018068632: Abutment Screw
• 07290018068625: Multiunit Screw
• 07290018068618: Standard Healing Cap Wide, 5.5 mm Diameter, 7mm Height
• 07290018068601: Standard Healing Cap Wide, 5.5 mm Diameter, 6mm Height
• 07290018068595: Standard Healing Cap Wide, 5.5 mm Diameter, 5mm Height
• 07290018068588: Standard Healing Cap Wide, 5.5 mm Diameter, 4mm Height
• 07290018068571: Standard Healing Cap Wide, 5.5 mm Diameter, 3mm Height
• 07290018068564: Standard Healing Cap Wide, 5.5 mm Diameter, 2mm Height
• 07290018068557: Standard Healing Cap 4.5 Diameter, 7mm Height
• 07290018068540: Standard Healing Cap 4.5mm Diameter, 2mm Height
• 07290018068533: Ball Abutment 6.0mm
• 07290018068526: Ball Abutment 5.0mm
• 07290018068519: Ball Abutment 4.0mm
• 07290018068502: Ball Abutment 3.0mm
• 07290018068496: Ball Abutment 2.0mm
• 07290018068489: Ball Abutment 1.0mm
• 07290018068472: Straight Multiunit Abutment 4.0 mm
• 07290018068465: Straight Multiunit Abutment 3.0 mm
• 07290018068458: Straight Multiunit Abutment 2.0 mm
• 07290018068441: Straight Multiunit Abutment 1.0 mm
• 07290018068434: Standard Angular Abutment 25 degrees, length 12
• 07290018068427: Standard Angular Abutment 25 degrees, 9 length
• 07290018068410: Standard Angular Abutment 15 degrees, 3.0 mm
• 07290018068403: Standard Angular Abutment 15 degrees, 2.0 mm
• 07290018068397: Standard Angular Abutment 15 degrees, 1.0 mm
• 07290018068380: Standard Shoulder Wide Abutment 4.0 mm
• 07290018068373: Standard Shoulder Wide Abutment 3.0 mm
• 07290018068366: Standard Shoulder Wide Abutment 2.0 mm
• 07290018068359: Standard Shoulder Wide Abutment 1.0 mm
• 07290018068342: Standard Shoulder Abutment 4.0 mm
• 07290018068335: Standard Shoulder Abutment 3.0 mm
• 07290018068328: Standard Shoulder Abutment 2.0 mm
• 07290018068311: Standard Shoulder Abutment 1.0 mm
• 07290018068304: Standard Narrow Abutment 11 mm
• 07290018068298: Standard Narrow Abutment 9.0 mm
• 07290018068281: Standard Narrow Abutment 7.0 mm
• 07290018068267: Spiral Shape Implant 5.0 mm diameter by 16 mm length
• 07290018068250: Spiral Shape Implant 4.2 mm diameter by 16 mm length
• 07290018068243: Spiral Shape Implant 3.75 mm diameter by 16 mm length
• 07290018068236: Spiral Shape Implant 3.3 mm diameter by 16 mm length
• 07290018068229: Spiral Shape Implant 6.0 mm diameter by 13 mm length
• 07290018068212: Spiral Shape Implant 5.0 mm diameter by 13 mm length
• 07290018068205: Spiral Shape Implant 4.2 mm diameter by 13 mm length
• 07290018068199: Spiral Shape Implant 3.7 mm diameter by 13 mm length
• 07290018068182: Spiral Shape Implant 3.3 mm diameter by 13 mm length
• 07290018068175: Spiral Shape Implant 6.0 mm diameter by 11.5 mm length
• 07290018068168: Spiral Shape Implant 5.0 mm diameter by 11.5 mm length
• 07290018068151: Spiral Shape Implant 4.2 mm diameter by 11.5 mm length
• 07290018068144: Spiral Shape Implant 3.75 mm diameter by 11.5 mm length