DIO Biotite-H Implant System SFN 3814H

GUDID 08806195922026

The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIG BIOTITE -H Implant System is designed for conventional two-stage procedures for single and multiple unit prosthetics. The DIO Biotite-H Implant System's screw-form dental implant consist of machined titanium. Screw's Diameter: Φ3.8mm, Φ4.1mm, Φ4.5mm, Φ4.8mm, Φ5.3mm. Length: 8.0mm, 10.mm, 12.0mm, 14.0mm. The implant's raw material is titanium and its alloys for surgical implant applications (as perASTM-F-67, A-STM-F-136). The special implant surface is consists of 100% calcium phosphate(CaHPO 42H20). BioTite-H Implant System is an electrochemically deposited calcium phosphate coating based upon abiomimetic process in which implants are coated in an electrolytic bath with a 15+±- 5m thin bioactive layer of a calcium phosphate composite. Biotite -H Implant System composed of the two calciumphosphates brushite(>95% )and HA(<5%).

DIO Corporation

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806195922026
• NIH Device Record Key: 936238d4-498a-4ad1-a73c-d84194682968
• Commercial Distribution Discontinuation: 2022-02-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DIO Biotite-H Implant System
• Version Model Number: SFN 3814H
• Catalog Number: SFN 3814H
• Company DUNS: 631085206
• Company Name: DIO Corporation
• 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: true
• 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

Customer Support Contacts

• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806195922026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073070

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: 4
• Public Version Date: 2022-02-25
• Device Publish Date: 2015-10-17

On-Brand Devices [DIO Biotite-H Implant System]

• 08806195922149: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth
• 08806195922132: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth
• 08806195922125: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth
• 08806195922118: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth
• 08806195922101: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth
• 08806195922095: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth
• 08806195922088: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth
• 08806195922064: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth
• 08806195922057: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth
• 08806195922033: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth
• 08806195922026: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth
• 08806195922019: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth
• 08806195922002: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth
• 08806195921999: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosth