Home GUDID EDWA110512161 Kera®starSplint Bio
Primary DI EDWA110512161
Brand Kera®starSplint Bio
Company Eisenbacher Dentalwaren ED GmbH
Model 11051216
Device description Kera®starSplint Bio Co-polymer for the production of therapeutic splints 98.0 x 16 mm
Published 2023-06-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name IQM Splint, Temporary Training
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IQM Splint, Temporary Training Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EDWA110512161 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Custom-made dental crown, polymer A device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.
Regulatory Flags# DUNS number 344231006 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published EDWAT100452131 Kera Ti5-Disc 98,5 x 13,5 mm T10045213 2023-10-04 EDWA130412121 Kera®Soft-Disc 98,0 x 12 mm 13041212 2023-06-23 EDWA130412141 Kera®Soft-Disc 98,0 x 14 mm 13041214 2023-06-23 EDWA130412161 Kera®Soft-Disc 98,0 x 16 mm 13041216 2023-06-23 EDWA130412201 Kera®Soft-Disc 98,0 x 20 mm 13041220 2023-06-23 EDWA131412181 Kera®Soft-Disc 98,0 x 18 mm 13041218 2023-06-23 EDWA1004000PK1 Kera S-Powder 1004000PK 2020-07-17 EDWAT100451081 Kera Ti5-Disc 99,5 x 8 mm T10045108 2020-02-06 EDWAT100451101 Kera Ti5-Disc 99,5 x 10 mm T10045110 2020-02-06 EDWAT100451121 Kera Ti5-Disc 99,5 x 12 mm T10045112 2020-02-06 EDWAT100451141 Kera Ti5-Disc 99,5 x 14 mm T10045114 2020-02-06 EDWAT100451151 Kera Ti5-Disc 99,5 x 15 mm T10045115 2020-02-06 EDWAT100451161 Kera Ti5-Disc 99,5 x 16 mm T10045116 2020-02-06 EDWAT100451181 Kera Ti5-Disc 99,5 x 18 mm T10045118 2020-02-06 EDWAT100451201 Kera Ti5-Disc 99,5 x 20 mm T10045120 2020-02-06 EDWAT100451251 Kera Ti5-Disc 99,5 x 25 mm T10045125 2020-02-06 EDWAT100451271 Kera Ti5-Disc 99,5 x 27 mm T10045127 2020-02-06 EDWAT100452081 Kera Ti5-Disc 98,5 x 8 mm T10045208 2020-02-06 EDWAT100452101 Kera Ti5-Disc 98,5 x 10 mm T10045210 2020-02-06 EDWAT100452121 Kera Ti5-Disc 98,5 x 12 mm T10045212 2020-02-06
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