Kera S-Powder

GUDID EDWA1004000P1

NPM - Cobalt-based dental sinter powder

Eisenbacher Dentalwaren ED GmbH

Dental casting non-noble alloy

• Primary Device ID: EDWA1004000P1
• NIH Device Record Key: c01c3228-a275-4fb5-9aa3-7f8a7840c412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kera S-Powder
• Version Model Number: 1004000P
• Company DUNS: 344231006
• Company Name: Eisenbacher Dentalwaren ED GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDWA1004000P1 [Primary]

FDA Product Code

• EJH: Alloy, Metal, Base

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-02

On-Brand Devices [Kera S-Powder]

• EDWA1004000P1: NPM - Cobalt-based dental sinter powder
• EDWA1004000PK1: NPM - Cobalt-based dental sinter powder - 5 kg Canister