Infinity Dental Implant System 01404037

GUDID 00614950000630

2.8MM BALL OD ABUTMENT HX 4HD 4.5CW 2CH W/RET SCREW Y

ACE SURGICAL SUPPLY CO., INC.

Screw endosteal dental implant, one-piece Screw endosteal dental implant, one-piece

• Primary Device ID: 00614950000630
• NIH Device Record Key: 3b03d1a0-4925-4f3d-b1ca-fc971beea71e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinity Dental Implant System
• Version Model Number: 01404037
• Catalog Number: 01404037
• Company DUNS: 042763706
• Company Name: ACE SURGICAL SUPPLY CO., INC.
• Device Count: 1
• DM Exempt: true
• 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: 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(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com

Device Dimensions

• Width: 4.5 Millimeter
• Width: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950000630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954513

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[00614950000630]

Radiation Sterilization

[00614950000630]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [Infinity Dental Implant System]

• 00614950000630: 2.8MM BALL OD ABUTMENT HX 4HD 4.5CW 2CH W/RET SCREW Y
• 00614950000623: 2.8MM BALL OD ABUT HX 4HD 4.5CW 1CH W/RET SCREW
• 00614950000616: 2.8MM BALL OD ABUT HX 4HD 4.5CW 3CH W/SCREW (TI6AL4VELI)
• 00614950000609: 2.8MM BALL OD ABUT HX 4HD 4.5CW 7CH W/SCREW (TI6AL4VELI)
• 00614950000593: 2.8MM BALL OD ABUT HX 4HD 4.5CW 5.5CH W/SCREW (TI6AL4VELI)
• 00614950000586: 2.8 MM BALL OD ABUT HX 4HD 4.5CW 4CH W/SCREW (TI6AL4VELI)