SPARK TPI 5-16

GUDID 07290110720582

DENTAL IMPLANT

HI-TEC IMPLANTS LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290110720582
• NIH Device Record Key: 065cb2a7-949a-408c-a016-919ee462e24d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPARK
• Version Model Number: TPI 5-16mm
• Catalog Number: TPI 5-16
• 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	07290110720582 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-22

On-Brand Devices [SPARK]

• 07290110722265: DENTAL IMPLANT
• 07290110720636: DENTAL IMPLANT
• 07290110720629: DENTAL IMPLANT
• 07290110720612: DENTAL IMPLANT
• 07290110720605: DENTAL IMPLANT
• 07290110720599: DENTAL IMPLANT
• 07290110720582: DENTAL IMPLANT
• 07290110720575: DENTAL IMPLANT
• 07290110720568: DENTAL IMPLANT
• 07290110720551: DENTAL IMPLANT
• 07290110720544: DENTAL IMPLANT
• 07290110720537: DENTAL IMPLANT
• 07290110720520: DENTAL IMPLANT
• 07290110720513: DENTAL IMPLANT
• 07290110720506: DENTAL IMPLANT
• 07290110720490: DENTAL IMPLANT
• 07290110720483: DENTAL IMPLANT
• 07290110720476: DENTAL IMPLANT
• 07290110720469: DENTAL IMPLANT
• 07290110720452: DENTAL IMPLANT
• 07290110720445: DENTAL IMPLANT
• 07290110720438: DENTAL IMPLANT