HI-TEC IMPLANTS N-HC-3.5-4.5

GUDID 07290110729363

HEALING CAP

HI-TEC IMPLANTS LTD.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07290110729363
• NIH Device Record Key: 4944d187-4883-4154-90e6-bc3a0c5436e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HI-TEC IMPLANTS
• Version Model Number: N-HC-3.5-4.5
• Catalog Number: N-HC-3.5-4.5
• 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	07290110729363 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-23
• Device Publish Date: 2024-12-15

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