ROOTT

GUDID 00810149980633

Dental Implant, ROOTT R, D 3.8 mm, L 12 mm.

TRATE LLC

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810149980633
• NIH Device Record Key: 78e825ea-0c4e-4f26-9821-f5ccd7a2a2eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROOTT
• Version Model Number: R3812
• Company DUNS: 129946338
• Company Name: TRATE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810149980626 [Primary]
GS1	00810149980633 [Package]; Contains: 00810149980626; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220022

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: 2024-11-20
• Device Publish Date: 2024-11-12

On-Brand Devices [ROOTT]

• 00810149980930: Dental Implant, ROOTT R, D 3.5 mm, L 14 mm.
• 00810149980497: Dental Implant, ROOTT R, D 3.5 mm, L 10 mm.
• 00810149980084: Dental Implant, ROOTT R, D 3.5 mm, L 12 mm.
• 00810149980015: Dental Implant, ROOTT R, D 3.5 mm, L 8 mm.
• 00810149980992: Dental Implant, ROOTT R, D 4.8 mm, L 12 mm.
• 00810149980978: Dental Implant, ROOTT R, D 4.8 mm, L 10 mm.
• 00810149980954: Dental Implant, ROOTT R, D 4.2 mm, L 12 mm.
• 00810149980633: Dental Implant, ROOTT R, D 3.8 mm, L 12 mm.
• 00810149980619: Dental Implant, ROOTT R, D 5.5 mm, L 10 mm.
• 00810149980596: Dental Implant, ROOTT R, D 5.5 mm, L 8 mm.
• 00810149980572: Dental Implant, ROOTT R, D 4.8 mm, L 8 mm.
• 00810149980558: Dental Implant, ROOTT R, D 4.2 mm, L 14 mm.
• 00810149980534: Dental Implant, ROOTT R, D 4.2 mm, L 8 mm.
• 00810149980510: Dental Implant, ROOTT R, D 3.8 mm, L 14 mm.
• 00810149980107: Dental Implant, ROOTT R, D 3.8 mm, L 8 mm.
• 00810149980060: Dental Implant, ROOTT R, D 3.8 mm, L 10 mm.
• 00810149980046: Dental Implant, ROOTT R, D 4.2 mm, L 10 mm.
• 00810149981395: Abutment, 15°, 1 mm, R.
• 00810149981456: Abutment, 25°, 3 mm, R.
• 00810149981432: Abutment, 25°, 1 mm, R.
• 00810149981388: Abutment, 4 mm, R.
• 00810149981340: Healing abutment, narrow, 6 mm, R.
• 00810149981326: Healing abutment, narrow, 2 mm, R.
• 00810149981449: Abutment, 25°, 2 mm, R.
• 00810149981357: Abutment, 1 mm, R.
• 00810149981418: Abutment, 15°, 3 mm, R.
• 00810149981296: Healing abutment, 4 mm, R.
• 00810149981272: Healing abutment, 1 mm, R.
• 00810149981425: Abutment, 15°, 4 mm, R.
• 00810149981463: Abutment, 25°, 4 mm, R.
• 00810149981333: Healing abutment, narrow, 4 mm, R.
• 00810149981319: Healing abutment, 6 mm, R.
• 00810149981371: Abutment, 3 mm, R.
• 00810149981364: Abutment, 2 mm, R.
• 00810149981401: Abutment, 15°, 2 mm, R.
• 00810149981289: Healing abutment, 2 mm, R.
• 00810149981302: Healing abutment, 5 mm, R.