Connect Internal Screw Dental Implant 16852001

GUDID 00614950003945

CONNECT PREPABLE ABUTMENT 5CW TEMPORARY SLEEVE 4HD

ACE SURGICAL SUPPLY CO., INC.

Screw endosteal dental implant, one-piece

• Primary Device ID: 00614950003945
• NIH Device Record Key: dd9c812c-9a6e-4945-9ced-ab00ac774e75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Connect Internal Screw Dental Implant
• Version Model Number: 16852001
• Catalog Number: 16852001
• 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: 5 Millimeter
• Width: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950003945 [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

[00614950003945]

Radiation Sterilization

[00614950003945]

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