OKTAGON Dental Implant TL TD 38415

GUDID EDRS384151

Tissue Level Implant Tapered Design Ø4,1x12

Hager & Meisinger Gesellschaft mit beschränkter Haftung

Screw endosteal dental implant, two-piece

• Primary Device ID: EDRS384151
• NIH Device Record Key: e5488c70-9bb8-4a8d-8778-58ddaec14c08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OKTAGON Dental Implant TL TD
• Version Model Number: 38415
• Catalog Number: 38415
• Company DUNS: 318034329
• Company Name: Hager & Meisinger Gesellschaft mit beschränkter Haftung
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de
• Phone: +492173398000
• Email: info@dental-ratio.de

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDRS384151 [Primary]
HIBCC	EDRS384159 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122807

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: 2019-02-13
• Device Publish Date: 2015-07-01

On-Brand Devices [OKTAGON Dental Implant TL TD]

• EDRS384151: Tissue Level Implant Tapered Design Ø4,1x12
• EDRS381501: Tissue Level Implant Tapered Design Ø4,1x10
• E0HM384151: Tissue Level Implant Tapered Design Ø4,1x12
• E0HM381501: Tissue Level Implant Tapered Design Ø4,1x10