SELF THREAD /LOGIC PLUS/SPARK AS

GUDID 07290110728533

TRANSFER SCREW

HI-TEC IMPLANTS LTD.

Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw Dental prosthesis/implant abutment screw

• Primary Device ID: 07290110728533
• NIH Device Record Key: 036be8ac-ed58-4c8a-b769-36a82e370247
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SELF THREAD /LOGIC PLUS/SPARK
• Version Model Number: AS
• Catalog Number: AS
• Company DUNS: 600710917
• Company Name: HI-TEC IMPLANTS 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110728533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941575

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-14

On-Brand Devices [SELF THREAD /LOGIC PLUS/SPARK]

• 07290110728564: ABUTMENT SCREW
• 07290110728557: ABUTMENT SCREW
• 07290110728540: TRANSFER SCREW
• 07290110728533: TRANSFER SCREW
• 07290110728526: ABUTMENT SCREW
• 07290110728519: ABUTMENT SCREW
• 07290110728502: ABUTMENT SCREW
• 07290110723996: ANTI-ROTATION ABUTMENT
• 07290110723989: ANTI-ROTATION ABUTMENT
• 07290110723972: ANTI-ROTATION ABUTMENT
• 07290110723965: ANTI-ROTATION ABUTMENT
• 07290110723958: ANTI-ROTATION ABUTMENT
• 07290110723941: ANTI-ROTATION ABUTMENT
• 07290110723934: ANTI-ROTATION ABUTMENT
• 07290110723927: ANTI-ROTATION ABUTMENT