SUMMIT BTI-11.5SR

GUDID 07290110721398

DENTAL IMPLANT

HI-TEC IMPLANTS LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 07290110721398
• NIH Device Record Key: 38ac2069-042b-4395-a3de-36b700863002
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUMMIT
• Version Model Number: BTI-11.5mmSR
• Catalog Number: BTI-11.5SR
• 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	07290110721398 [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 [SUMMIT]

• 07290110728946: TRANSFER SCREW
• 07290110728939: ABUTMENT SCREW
• 07290110728922: ABUTMENT SCREW
• 07290110728915: ABUTMENT SCREW
• 07290110728038: UNIVERSAL UNIT ANGULATED ABUTMENT
• 07290110728021: UNIVERSAL UNIT ANGULATED ABUTMENT
• 07290110728014: UNIVERSAL UNIT ABUTMENT
• 07290110728007: UNIVERSAL UNIT ABUTMENT
• 07290110727994: UNIVERSAL UNIT ABUTMENT
• 07290110727444: IMPLANT ANALOG
• 07290110727284: TRANSFER
• 07290110727277: TRANSFER
• 07290110727260: TRANSFER
• 07290110726645: BALL-ATTACHMENT ABUTMENT
• 07290110726638: BALL-ATTACHMENT ABUTMENT
• 07290110724870: CASTABLE ABUTMENT
• 07290110724863: CASTABLE ABUTMENT
• 07290110724511: ANGULATED ABUTMENT
• 07290110724504: ANGULATED ABUTMENT
• 07290110724276: ANTI-ROTATION ABUTMENT
• 07290110722920: HEALING CAP
• 07290110722913: HEALING CAP
• 07290110722678: IMPLANT SCREW
• 07290110721510: DENTAL IMPLANT
• 07290110721503: DENTAL IMPLANT
• 07290110721497: DENTAL IMPLANT
• 07290110721480: DENTAL IMPLANT
• 07290110721473: DENTAL IMPLANT
• 07290110721466: DENTAL IMPLANT
• 07290110721459: DENTAL IMPLANT
• 07290110721442: DENTAL IMPLANT
• 07290110721435: DENTAL IMPLANT
• 07290110721428: DENTAL IMPLANT
• 07290110721411: DENTAL IMPLANT
• 07290110721404: DENTAL IMPLANT
• 07290110721398: DENTAL IMPLANT
• 07290110721381: DENTAL IMPLANT
• 07290110721374: DENTAL IMPLANT