DD Prefab Starter Kit CAM 1101.5

GUDID EDDICAM110159

The DD Prefab Starter Kit SilaMill N4 contains one SilaMill N4 holder, one bar, four black M4 screws, three silver M4 screws, one screwdriver SW 3mm, three calibration bodies and three prefabs.

Dental Direkt GmbH

Dental implant suprastructure, permanent, preformed

• Primary Device ID: EDDICAM110159
• NIH Device Record Key: a2456fbd-3ef6-4045-a320-7f940865bf4c
• Commercial Distribution Discontinuation: 2024-02-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DD Prefab Starter Kit
• Version Model Number: SilaMill N4
• Catalog Number: CAM 1101.5
• Company DUNS: 313214171
• Company Name: Dental Direkt GmbH
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de
• Phone: +495225863190
• Email: info@dentaldirekt.de

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDDICAM110151 [Primary]
HIBCC	EDDICAM110159 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191111

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

[EDDICAM110159]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-27
• Device Publish Date: 2024-02-19

On-Brand Devices [DD Prefab Starter Kit]

• EDDICAM110449: The DD Prefab Starter Kit SilaMill R5 contains one SilaMill R5 ring holder, two bars, four black
• EDDICAM110159: The DD Prefab Starter Kit SilaMill N4 contains one SilaMill N4 holder, one bar, four black M4 sc
• EDDICAM05179: The DD Prefab Starter Kit MB contains one ring holder, two bars, four black M4 screws, six silve
• EDDICAM05119: The DD Prefab Starter Kit CORiTEC contains one ring holder, two bars, four black M4 screws, four