Genesis ACTIVE

GUDID D768GA220040

Genesis Active Conical Healing Abutment, Concave, Ø3.5, H4.0mm

KEYSTONE DENTAL, INC.

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• Primary Device ID: D768GA220040
• NIH Device Record Key: 7a24f566-1ead-41d7-abef-4e6ba607593c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesis ACTIVE
• Version Model Number: GA22004
• Company DUNS: 787471015
• Company Name: KEYSTONE DENTAL, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com
• Phone: +1(866)902-9272
• Email: customersupport@keystonedental.com

Device Dimensions

• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter
• Height: 4 Millimeter
• Outer Diameter: 3.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D768GA220040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223814

FDA Product Code

• NHA: Abutment, implant, dental, endosseous

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: 2023-06-27
• Device Publish Date: 2023-06-19

On-Brand Devices [Genesis ACTIVE]

• D768GA716620: Genesis Active Conical Impression Post, Concave, Open/Close Tray, Ø6.0
• D768GA716610: Genesis Active Conical Impression Post, Concave, Open/Close Tray, Ø4.5
• D768GA716600: Genesis Active Conical Impression Post, Concave, Open/Close Tray, Ø3.5
• D768GA716410: GA Conical Torx® Screw ELLIPTIBase®/ANGLEBase® Abutment
• D768GA716400: GA Conical Multi-Unit ANGLEBase® Abutment Final Screw, WP, Torx®
• D768GA716380: GA Conical ANGLEBase® Torx® Ball Screwdriver, 24mm
• D768GA716370: GA Conical ANGLEBase® Torx® Ball Screwdriver, 20mm
• D768GA716360: GA Conical Multi-Unit ANGLEBase® Abutment Final Screw, RP, Torx®
• D768GA716350: GA Conical Angled Multi Unit Abutment Screw, RP/WP
• D768GA716320: GA Conical ELLIPTIBase® Engaging, 1.0mm Cuff, Hex Flat
• D768GA716310: GA Conical ELLIPTIBase® Engaging, 1.0mm Cuff, Hex Corner
• D768GA716300: GA Conical C-Base® Ti Base Engaging, 3.0mm Cuff, Ø5.5
• D768GA716290: GA Conical C-Base® Ti Base Engaging, 2.0mm Cuff, Ø5.5
• D768GA716280: GA Conical C-Base® Ti Base Engaging, 1.0mm Cuff, Ø5.5
• D768GA716270: GA Conical C-Base® Ti Base Engaging, 3.0mm Cuff, Ø3.8/4.5
• D768GA716260: GA Conical C-Base® Ti Base Engaging, 2.0mm Cuff, Ø3.8/4.5
• D768GA716250: GA Conical C-Base® Ti Base Engaging, 1.0mm Cuff, Ø3.8/4.5
• D768GA716240: GA Conical C-Base® Scan Post with Screw
• D768GA716230: GA Conical Premilled Titanium Blank Ø4.5/5.5, 14mm
• D768GA716220: GA Conical Premilled Titanium Blank Ø3.5/3.8/4.5, 10mm
• D768GA716210: GA Conical ANGLEBase® Non-Engaging, Concave Ø5.5, 1.0mm Cuff, 4.0mm H
• D768GA716200: GA Conical ANGLEBase® Non-Engaging, Concave Ø4.5, 1.0mm Cuff, 4.0mm H
• D768GA716190: GA Conical ANGLEBase® Engaging, Concave Ø5.5, 1.0mm Cuff, 4.0mm H
• D768GA716180: GA Conical ANGLEBase® Engaging, Concave Ø4.5, 1.0mm Cuff, 4.0mm H
• D768GA716170: GA Conical Ti Base Non-Engaging, Concave Ø5.5, 3.0mm Cuff, For Ø5.5 Implants
• D768GA716160: GA Conical Ti Base Engaging, Concave Ø5.5, 3.0mm Cuff, For Ø5.5 Implants
• D768GA716150: GA Conical Ti Base Non-Engaging, Concave Ø5.5, 2.0mm Cuff, For Ø5.5 Implants
• D768GA716140: GA Conical Ti Base Engaging, Concave Ø5.5, 2.0mm Cuff, For Ø5.5 Implants
• D768GA716130: GA Conical Ti Base Non-Engaging, Concave Ø5.5, 1.0mm Cuff, For Ø5.5 Implants
• D768GA716120: GA Conical Ti Base Engaging, Concave Ø5.5, 1.0mm Cuff, For Ø5.5 Implants
• D768GA716110: GA Conical Ti Base Non-Engaging, Concave Ø4.5, 3.0mm Cuff, For Ø3.8/4.5 Implants
• D768GA716100: GA Conical Ti Base Engaging, Concave Ø4.5, 3.0mm Cuff, For Ø3.8/4.5 Implants
• D768GA716090: GA Conical Ti Base Non-Engaging, Concave Ø4.5, 2.0mm Cuff, For Ø3.8/4.5 Implants
• D768GA716080: GA Conical Ti Base Engaging, Concave Ø4.5, 2.0mm Cuff, For Ø3.8/4.5 Implants
• D768GA716070: GA Conical Ti Base Non-Engaging, Concave Ø4.5, 1.0mm Cuff, For Ø3.8/4.5 Implants
• D768GA716060: GA Conical Ti Base Engaging, Concave Ø4.5, 1.0mm Cuff, For Ø3.8/4.5 Implants
• D768GA716050: GA Conical Intraoral Scan Body, Ø4.0
• D768GA716040: GA Conical Multi-Unit Abutment Analog, WP
• D768GA716030: GA Conical Multi-Unit Impression Post Open Tray/Closed Tray, WP
• D768GA716020: GA Conical Multi-Unit Abutment Analog, RP
• D768GA716010: GA Conical Multi-Unit Impression Post Open Tray/Closed Tray, RP
• D768GA716000: GA Conical Multi-Unit ANGLEBase® Torx®, WP, Non-Engaging
• D768GA715990: GA Conical Multi-Unit ANGLEBase® Torx®, RP, Non-Engaging
• D768GA715980: GA Conical Multi-Unit ANGLEBase® Abutment Lab Screw, WP, Torx®
• D768GA715970: GA Conical Multi-Unit ANGLEBase® Abutment Lab Screw, RP, Torx®
• D768GA715960: GA Conical Multi-Unit Final Prosthetic Screw, WP, Ø1.25 Hex
• D768GA715950: GA Conical Multi-Unit Final Prosthetic Screw, RP, Ø1.25 Hex
• D768GA715940: GA Conical Multi-Unit Lab Prosthetic Screw, WP, Ø1.25 Hex
• D768GA715930: GA Conical Multi-Unit Lab Prosthetic Screw, RP, Ø1.25 Hex
• D768GA715920: GA Conical Multi-Unit Abutment Plastic Sleeve, WP, Non-Engaging