HI-TEC IMPLANTS NPI 3.5-10

GUDID 07290110729011

DENTAL IMPLANT

HI-TEC IMPLANTS LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290110729011
• NIH Device Record Key: 4595dc6a-d223-4db8-9c0d-e20650e1691d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HI-TEC IMPLANTS
• Version Model Number: NPI 3.5-10mm
• Catalog Number: NPI 3.5-10
• 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	07290110729011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941575

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-06
• Device Publish Date: 2024-11-28

On-Brand Devices [HI-TEC IMPLANTS]

• 07290110729141: DENTAL IMPLANT
• 07290110729134: DENTAL IMPLANT
• 07290110729127: DENTAL IMPLANT
• 07290110729110: DENTAL IMPLANT
• 07290110729103: DENTAL IMPLANT
• 07290110729097: DENTAL IMPLANT
• 07290110729080: DENTAL IMPLANT
• 07290110729073: DENTAL IMPLANT
• 07290110729066: DENTAL IMPLANT
• 07290110729059: DENTAL IMPLANT
• 07290110729042: DENTAL IMPLANT
• 07290110729035: DENTAL IMPLANT
• 07290110729028: DENTAL IMPLANT
• 07290110729011: DENTAL IMPLANT
• 07290110729004: DENTAL IMPLANT
• 07290110729394: HEALING CAP
• 07290110729387: HEALING CAP
• 07290110729370: HEALING CAP
• 07290110729363: HEALING CAP
• 07290110729356: HEALING CAP
• 07290110729233: BALL-ATTACHMENT ABUTMENT
• 07290110729226: ANGULATED ABUTMENT
• 07290110729219: ANTIROTATION ABUTMENT
• 07290110729202: ANTIROTATION ABUTMENT
• 07290110729196: ANTIROTATION ABUTMENT
• 07290110729189: ANTIROTATION ABUTMENT
• 07290110729172: ANTIROTATION ABUTMENT
• 07290110729165: TRANSFER
• 07290110729158: TRANSFER