TITAN IMPLANTS INC.

GUDID 00842448115966

6.0mm Platform Gold Cylinder Long Plastic Sleeve Locking

TITAN IMPLANT INC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00842448115966
• NIH Device Record Key: dbeb36b2-713d-48d5-bc3b-313deb210af2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TITAN IMPLANTS INC.
• Version Model Number: SRS-6CLPSL
• Company DUNS: 115545837
• Company Name: TITAN IMPLANT INC
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842448115966 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042971

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00842448115966]

Moist Heat or Steam Sterilization

[00842448115966]

Moist Heat or Steam Sterilization

[00842448115966]

Moist Heat or Steam Sterilization

[00842448115966]

Moist Heat or Steam Sterilization

[00842448115966]

Moist Heat or Steam Sterilization

[00842448115966]

Moist Heat or Steam Sterilization

[00842448115966]

Moist Heat or Steam Sterilization

[00842448115966]

Moist Heat or Steam Sterilization

[00842448115966]

Moist Heat or Steam Sterilization

[00842448115966]

Moist Heat or Steam Sterilization

[00842448115966]

Moist Heat or Steam Sterilization

[00842448115966]

Moist Heat or Steam Sterilization

[00842448115966]

Moist Heat or Steam Sterilization

[00842448115966]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-27
• Device Publish Date: 2020-08-19

On-Brand Devices [TITAN IMPLANTS INC.]

• 00842448115614: 6.5mm TG Hex Abutment Impression Coping
• 00842448115584: 0.048'' Hex Driver Marked One Inch
• 00842448115577: 6.5mm TG Hex Abutment Plastic Sleeve Hex
• 00842448115560: 6.5mm TG Hex Abutment Analog
• 00842448115966: 6.0mm Platform Gold Cylinder Long Plastic Sleeve Locking
• 00842448116413: 3.25mm External Hex Straight Locking Implant Abutment Flat GH 1.5mm