Connect Internal Screw Dental Implant 19453201

GUDID 00614950004034

2MM TWO PIECE PREPABLE ABUTMEN SCREW CONNECT 4MM SYSTEM TI 6AL 4V ELI

ACE SURGICAL SUPPLY CO., INC.

Screw endosteal dental implant, one-piece

• Primary Device ID: 00614950004034
• NIH Device Record Key: ea805339-f62a-47eb-9bec-f8c6950bd04a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Connect Internal Screw Dental Implant
• Version Model Number: 19453201
• Catalog Number: 19453201
• 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 Millimeter
• Width: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950004034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041759

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[00614950004034]

Radiation Sterilization

[00614950004034]

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 [Connect Internal Screw Dental Implant]

• 00614950004041: 1.5MM TWO PIECE PREPABLE ABUTMENT SCREW CONNECT 4MM SYS TI 6AL 4V ELI
• 00614950004034: 2MM TWO PIECE PREPABLE ABUTMEN SCREW CONNECT 4MM SYSTEM TI 6AL 4V ELI
• 00614950003990: CONNECT SCREW 5.5MM FOR TAPER ABUTMENT 4MM SYSTEM TI 6AL 4V ELI
• 00614950003983: CONNECT SCREW 3MM FOR TAPERED ABUTMENT 4MM SYSTEM TI 6AL 4V ELI
• 00614950003976: CONNECT PREPABLE ABUTMENT 6CW TEMPORARY SLEEVE 5HD
• 00614950003969: CONNECT PREPABLE ABUTMENT 7CW TEMPORARY SLEEVE 4HD
• 00614950003952: CONNECT PREPABLE ABUTMENT 6CW TEMPORARY SLEEVE 4HD
• 00614950003945: CONNECT PREPABLE ABUTMENT 5CW TEMPORARY SLEEVE 4HD