OKTAGON Dental Implant BL RC 22001

GUDID EDRS220011

Bone Level Implant Regular Connect Ø4.1x8mm

Hager & Meisinger Gesellschaft mit beschränkter Haftung

Screw endosteal dental implant, two-piece

• Primary Device ID: EDRS220011
• NIH Device Record Key: d22689c2-d52c-44c4-a4d2-636bef57c71c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OKTAGON Dental Implant BL RC
• Version Model Number: 22001
• Catalog Number: 22001
• 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	EDRS220011 [Primary]
HIBCC	EDRS220019 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143539

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: 2015-10-01

On-Brand Devices [OKTAGON Dental Implant BL RC]

• EDRS220081: Bone Level Implant Regular Connect Ø4.8x14mm
• EDRS220071: Bone Level Implant Regular Connect Ø4.8x12mm
• EDRS220061: Bone Level Implant Regular Connect Ø4.8x10mm
• EDRS220051: Bone Level Implant Regular Connect Ø4.8x8mm
• EDRS220041: Bone Level Implant Regular Connect Ø4.1x14mm
• EDRS220031: Bone Level Implant Regular Connect Ø4.1x12mm
• EDRS220021: Bone Level Implant Regular Connect Ø4.1x10mm
• EDRS220011: Bone Level Implant Regular Connect Ø4.1x8mm
• E0HM220081: Bone Level Implant Regular Connect Ø4.8x14mm
• E0HM220071: Bone Level Implant Regular Connect Ø4.8x12mm
• E0HM220061: Bone Level Implant Regular Connect Ø4.8x10mm
• E0HM220051: Bone Level Implant Regular Connect Ø4.8x8mm
• E0HM220041: Bone Level Implant Regular Connect Ø4.1x14mm
• E0HM220031: Bone Level Implant Regular Connect Ø4.1x12mm
• E0HM220021: Bone Level Implant Regular Connect Ø4.1x10mm
• E0HM220011: Bone Level Implant Regular Connect Ø4.1x8mm