8 MM IC WIDE DIAMETER NON-EXPANDABLE IMPLANT

GUDID 00852550007332

Bio-Dent, Inc.

Screw endosteal dental implant, one-piece

• Primary Device ID: 00852550007332
• NIH Device Record Key: dc45388e-4d8a-4a22-a20e-72d82a1b900a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8 MM IC WIDE DIAMETER NON-EXPANDABLE IMPLANT
• Version Model Number: 3808IWD
• Company DUNS: 017725036
• Company Name: Bio-Dent, 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: 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 Dimensions

• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852550007332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082573

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2016-12-22

Devices Manufactured by Bio-Dent, Inc.

• 00852550007165 - 8mm ULTRA TOOTH SOLID WIDE IMPLANT: 2018-07-06
• 00852550007172 - 10 MM ULTRA TOOTH SOLID WIDE IMPLANT: 2018-07-06
• 00852550007189 - 13 MM ULTRA TOOTH SOLID WIDE IMPLANT: 2018-07-06
• 00852550007196 - 16 MM ULTRA TOOTH SOLID WIDE IMPLANT: 2018-07-06
• 00852550007202 - 8 MM ULTRA TOOTH IMPLANT: 2018-07-06
• 00852550007219 - 10 MM ULTRA TOOTH IMPLANT: 2018-07-06
• 00852550007226 - 13 MM ULTRA TOOTH IMPLANT: 2018-07-06
• 00852550007233 - 16 MM ULTRA TOOTH IMPLANT: 2018-07-06