EXPANDED HEALING CAP MULTI-IM WIDE PLATFORM

GUDID 08435389820345

BIOTECHNOLOGY INSTITUTE SL

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08435389820345
• NIH Device Record Key: 1805214f-98b4-4b01-aebd-24704abe9ad6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPANDED HEALING CAP MULTI-IM WIDE PLATFORM
• Version Model Number: TPMIPAEX
• Company DUNS: 461665312
• Company Name: BIOTECHNOLOGY INSTITUTE SL
• Device Count: 1
• DM Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2156464067
• Email: janderson@bti-implant.us
• Phone: 2156464067
• Email: janderson@bti-implant.us
• Phone: 2156464067
• Email: janderson@bti-implant.us
• Phone: 2156464067
• Email: janderson@bti-implant.us
• Phone: 2156464067
• Email: janderson@bti-implant.us
• Phone: 2156464067
• Email: janderson@bti-implant.us
• Phone: 2156464067
• Email: janderson@bti-implant.us
• Phone: 2156464067
• Email: janderson@bti-implant.us
• Phone: 2156464067
• Email: janderson@bti-implant.us
• Phone: 2156464067
• Email: janderson@bti-implant.us
• Phone: 2156464067
• Email: janderson@bti-implant.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435389820345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022258

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[08435389820345]

Moist Heat or Steam Sterilization

[08435389820345]

Moist Heat or Steam Sterilization

[08435389820345]

Moist Heat or Steam Sterilization

[08435389820345]

Moist Heat or Steam Sterilization

[08435389820345]

Moist Heat or Steam Sterilization

[08435389820345]

Moist Heat or Steam Sterilization

[08435389820345]

Moist Heat or Steam Sterilization

[08435389820345]

Moist Heat or Steam Sterilization

[08435389820345]

Moist Heat or Steam Sterilization

[08435389820345]

Moist Heat or Steam Sterilization

[08435389820345]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-12
• Device Publish Date: 2019-06-04

Devices Manufactured by BIOTECHNOLOGY INSTITUTE SL

• 08435389823803 - SHORT DRILL; Ø 6MM: 2023-08-30
• 08435389825296 - WIDE PLATFORM POSITIONER (2 UNITS): 2023-07-07
• 08435389825319 - TINY® PLATFORM POSITIONER (2 UNITS): 2023-07-07
• 08435389825333 - UNIVERSAL PLATFORM POSITIONER (2 UNITS): 2023-07-07
• 08435389825357 - UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS): 2023-07-07
• 08435389825364 - SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS): 2023-07-07
• 08435389825302 - SHORT POSITIONER FOR WIDE PLATFORM (2 UNITS): 2023-07-07
• 08435389825326 - SHORT POSITIONER FOR TINY® PLATFORM (2 UNITS): 2023-07-07