LOGIC PLUS/SPARK IS-LP

GUDID 07290110722593

IMPLANT SCREW

HI-TEC IMPLANTS LTD.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07290110722593
• NIH Device Record Key: 4508da32-2e5a-4a04-a3e4-8bf19567cc73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOGIC PLUS/SPARK
• Version Model Number: IS-LP
• Catalog Number: IS-LP
• 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: true
• 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	07290110722593 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2017-06-07

Devices Manufactured by HI-TEC IMPLANTS LTD.

• 07290110723927 - SELF THREAD /LOGIC PLUS/SPARK: 2019-11-08 ANTI-ROTATION ABUTMENT
• 07290110723934 - SELF THREAD /LOGIC PLUS/SPARK: 2019-11-08 ANTI-ROTATION ABUTMENT
• 07290110723941 - SELF THREAD /LOGIC PLUS/SPARK: 2019-11-08 ANTI-ROTATION ABUTMENT
• 07290110723958 - SELF THREAD /LOGIC PLUS/SPARK: 2019-11-08 ANTI-ROTATION ABUTMENT
• 07290110723965 - SELF THREAD /LOGIC PLUS/SPARK: 2019-11-08 ANTI-ROTATION ABUTMENT
• 07290110723972 - SELF THREAD /LOGIC PLUS/SPARK: 2019-11-08 ANTI-ROTATION ABUTMENT
• 07290110723989 - SELF THREAD /LOGIC PLUS/SPARK: 2019-11-08 ANTI-ROTATION ABUTMENT
• 07290110723996 - SELF THREAD /LOGIC PLUS/SPARK: 2019-11-08 ANTI-ROTATION ABUTMENT