BIOTANIUM

GUDID 00810123450084

4.5mm X 13mm Implant

Basic Dental Implant Systems, Inc.

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• Primary Device ID: 00810123450084
• NIH Device Record Key: eee6a66e-1bf5-4011-891f-8477d85409f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOTANIUM
• Version Model Number: O4513S
• Company DUNS: 933988979
• Company Name: Basic Dental Implant Systems, 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810123450084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082749

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: 2023-09-28
• Device Publish Date: 2023-09-20

On-Brand Devices [BIOTANIUM]

• 00810123450008: 3.5mm X 11mm Implant
• 00810123450190: 6.0mm X 15mm Implant
• 00810123450183: 6.0mm X 13mm Implant
• 00810123450176: 6.0mm X 12mm Implant
• 00810123450169: 6.0mm X 11mm Implant
• 00810123450152: 6.0mm X 10mm Implant
• 00810123450145: 6.0mm X 8mm Implant
• 00810123450138: 5.0mm X 15mm Implant
• 00810123450121: 5.0mm X 13mm Implant
• 00810123450114: 5.0mm X 11mm Implant
• 00810123450107: 5.0mm X 9mm Implant
• 00810123450091: 4.5mm X 15mm Implant
• 00810123450084: 4.5mm X 13mm Implant
• 00810123450077: 4.5mm X 11mm Implant
• 00810123450060: 4.5mm X 9mm Implant
• 00810123450053: 4.0mm X 15mm Implant
• 00810123450046: 4.0mm X 13mm Implant
• 00810123450039: 4.0mm X 11mm Implant
• 00810123450022: 3.5mm X 15mm Implant
• 00810123450015: 3.5mm X 13mm Implant
• 00810123452736: 3.5mm X 8.5mm Implant & Healing Screw
• 00810123452729: 3.5mm X 10mm Implant & Healing Screw
• 00810123452712: 3.5mm X 11.5mm Implant & Healing Screw
• 00810123452705: 3.5mm X 13mm Implant & Healing Screw
• 00810123452699: 3.5mm X 14.5mm Implant & Healing Screw
• 00810123452682: 3.5mm X 16mm Implant & Healing Screw
• 00810123452675: 4.3mm X 8.5mm Implant & Healing Screw
• 00810123452668: 4.3mm X 10mm Implant & Healing Screw
• 00810123452651: 4.3mm X 11.5mm Implant & Healing Screw
• 00810123452644: 4.3mm X 13mm Implant & Healing Screw
• 00810123452637: 4.3mm X 14.5mm Implant & Healing Screw
• 00810123452620: 5.0mm X 8.5mm Implant & Healing Screw
• 00810123452613: 5.0mm X 8.5mm Implant & Healing Screw
• 00810123452606: 5.0mm X 10mm Implant & Healing Screw
• 00810123452590: 5.0mm X 11.5mm Implant & Healing Screw
• 00810123452583: 5.0mm X 13mm Implant & Healing Screw
• 00810123452576: 5.0mm X 14.5mm Implant & Healing Screw
• 00810123455423: Drill Extender
• 00810123455416: Hard Bone Drill
• 00810123455409: 5.7mmDrill – 21mm Length
• 00810123455393: 5.7mmDrill – 16mm Length
• 00810123455386: 4.8mmDrill – 21mm Length
• 00810123455379: 4.8mmDrill – 16mm Length
• 00810123455362: 4.4mmDrill – 21mm Length
• 00810123455355: 4.4mmDrill – 16mm Length
• 00810123455348: 3.9mmDrill – 21mm Length
• 00810123455331: 3.9mmDrill – 16mm Length
• 00810123455324: 3.4mmDrill – 21mm Length
• 00810123455317: 3.4mm Drill – 16mm Length
• 00810123455300: 2.9mm Drill – 21mm Length