SELF THREAD/LOGIC PLUS/SPARK AST

GUDID 07290110727000

TRANSFER

HI-TEC IMPLANTS LTD.

Dental implant system

• Primary Device ID: 07290110727000
• NIH Device Record Key: 7ebdc753-1ac0-4860-a811-5fe9621ff5af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SELF THREAD/LOGIC PLUS/SPARK
• Version Model Number: AST
• Catalog Number: AST
• 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	07290110727000 [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: 2017-06-13

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

• 07290110728205: MODULAR SYSTEM ABUTMENT
• 07290110728199: MODULAR SYSTEM ABUTMENT
• 07290110728182: MODULAR SYSTEM ABUTMENT
• 07290110728175: MODULAR SYSTEM ABUTMENT
• 07290110727635: UNIVERSAL UNIT ANGULATED ABUTMENT
• 07290110727628: UNIVERSAL UNIT ANGULATED ABUTMENT
• 07290110727611: UNIVERSAL UNIT ABUTMENT
• 07290110727604: UNIVERSAL UNIT ABUTMENT
• 07290110727598: UNIVERSAL UNIT ABUTMENT
• 07290110727581: UNIVERSAL UNIT ABUTMENT
• 07290110727376: IMPLANT ANALOG
• 07290110727017: TRANSFER
• 07290110727000: TRANSFER
• 07290110726997: TRANSFER
• 07290110726980: TRANSFER
• 07290110726768: NYLON CAP
• 07290110726751: NYLON CAP
• 07290110726744: NYLON CAP
• 07290110726737: NYLON CAP
• 07290110726720: METAL HOUSING
• 07290110726713: ANALOG
• 07290110726409: BALL-ATTACHMENT ABUTMENT
• 07290110726393: BALL-ATTACHMENT ABUTMENT
• 07290110726386: BALL-ATTACHMENT ABUTMENT
• 07290110726379: BALL-ATTACHMENT ABUTMENT
• 07290110726270: TOOL
• 07290110726263: TOOL
• 07290110726256: ANALOG
• 07290110726249: ANALOG
• 07290110726232: TRANSFER
• 07290110726225: FIXATION SCREW
• 07290110726218: FIXATION SCREW
• 07290110726201: FIXATION SCREW
• 07290110726195: CYLINDER
• 07290110726188: CYLINDER
• 07290110726171: CYLINDER
• 07290110726164: CYLINDER
• 07290110726157: CYLINDER
• 07290110726096: FIXED DETACHABLE ABUTMENT
• 07290110726089: FIXED DETACHABLE ABUTMENT
• 07290110726072: FIXED DETACHABLE ABUTMENT
• 07290110726065: FIXED DETACHABLE ABUTMENT
• 07290110726058: FIXED DETACHABLE ABUTMENT
• 07290110726041: FIXED DETACHABLE ABUTMENT
• 07290110725792: PEEK ANGULATED ABUTMENT
• 07290110725785: PEEK ANGULATED ABUTMENT
• 07290110725778: PEEK ABUTMENT
• 07290110725600: SCAN ABUTMENT
• 07290110725594: SCAN ABUTMENT
• 07290110725426: T-BASE ABUTMENT