Kera®starSplint Bio

GUDID EDWA110512161

Kera®starSplint Bio Co-polymer for the production of therapeutic splints 98.0 x 16 mm

Eisenbacher Dentalwaren ED GmbH

Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer Custom-made dental crown, polymer

• Primary Device ID: EDWA110512161
• NIH Device Record Key: 035e10dc-3777-43d8-98ec-0ec0f10316c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kera®starSplint Bio
• Version Model Number: 11051216
• 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: true
• 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	EDWA110512161 [Primary]

FDA Product Code

• IQM: Splint, Temporary Training

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-03
• Device Publish Date: 2023-06-23

Devices Manufactured by Eisenbacher Dentalwaren ED GmbH

• EDWAT100452131 - Kera Ti5-Disc 98,5 x 13,5 mm: 2023-10-12 Ti6Al4V based dental alloy for milling, grade 5, Dimension: 98,5 mm x 13,5 mm
• EDWA110512161 - Kera®starSplint Bio: 2023-07-03Kera®starSplint Bio Co-polymer for the production of therapeutic splints 98.0 x 16 mm
• EDWA110512161 - Kera®starSplint Bio: 2023-07-03 Kera®starSplint Bio Co-polymer for the production of therapeutic splints 98.0 x 16 mm
• EDWA130412121 - Kera®Soft-Disc 98,0 x 12 mm: 2023-07-03 Non-precious-metal dental milling alloy on cobalt-base, type 4; Dimension: 98,0 mm x 12 mm
• EDWA130412141 - Kera®Soft-Disc 98,0 x 14 mm: 2023-07-03 Non-precious-metal dental milling alloy on cobalt-base, type 4; Dimension: 98,0 mm x 14 mm
• EDWA130412161 - Kera®Soft-Disc 98,0 x 16 mm: 2023-07-03 Non-precious-metal dental milling alloy on cobalt-base, type 4; Dimension: 98,0 mm x 16 mm
• EDWA130412201 - Kera®Soft-Disc 98,0 x 20 mm: 2023-07-03 Non-precious-metal dental milling alloy on cobalt-base, type 4; Dimension: 98,0 mm x 20 mm
• EDWA131412181 - Kera®Soft-Disc 98,0 x 18 mm: 2023-07-03 Non-precious-metal dental milling alloy on cobalt-base, type 4; Dimension: 98,0 mm x 18 mm
• EDWA1004000PK1 - Kera S-Powder: 2020-07-27 NPM - Cobalt-based dental sinter powder - 5 kg Canister