FDA.report

Tizian Blank NEM, 98 x 10 mm

Primary DI
ESDG2201051
Brand
Tizian Blank NEM, 98 x 10 mm
Company
Schütz Dental GmbH
Model
220105
Device description
Shape 98 mm, round The CoCr round blank for milling crowns, bridges and bars. With a Vickers hardness of 320 HV, this CoCr material can be milled and polished very well. Naturally, the material is free from beryllium and nickel.
Published
2016-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EJHAlloy, Metal, Base

Product Code Classifications

CodeDeviceSpecialtyClass
EJHAlloy, Metal, BaseDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESDG2201051PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental casting non-noble alloyA material composed primarily of non-noble metals [e.g., includes alloys such as cobalt-chrome (Co-Cr), nickel-chromium, titanium (Ti)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store blanks in a dry place

Sterilization Methods

Method

Regulatory Flags

DUNS number
315830349
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
ESDG6875531CoCr laser welding wire 0.35 mm6875532017-01-30
ESDG6875541CoCr laser welding wire 0.5 mm6875542017-01-30
ESDG6246711Tizian Ceramic Opaque Dentin A26246712016-09-08
ESDG6246721Tizian Ceramic Opaque Dentin A36246722016-09-08
ESDG6246731Tizian Ceramic Opaque Dentin A3.56246732016-09-08
ESDG6246741Tizian Ceramic Opaque Dentin A46246742016-09-08
ESDG6246761Tizian Ceramic Opaque Dentin B26246762016-09-08
ESDG6246771Tizian Ceramic Opaque Dentin B36246772016-09-08
ESDG6246801Tizian Ceramic Opaque Dentin C26246802016-09-08
ESDG6246811Tizian Ceramic Opaque Dentin C36246812016-09-08
ESDG6246831Tizian Ceramic Opaque Dentin D26246832016-09-08
ESDG6246861Tizian Ceramic Transparent Tclear TC6246862016-09-08
ESDG6246871Tizian Ceramic Transparent Tclear TC6246872016-09-08
ESDG6246881Tizian Ceramic Transparent Orange T36246882016-09-08
ESDG6246891Tizian Ceramic Transparent Brown T46246892016-09-08
ESDG6246901Tizian Ceramic Transparent Grey T56246902016-09-08
ESDG6246911Tizian Ceramic Transparent Blue T66246912016-09-08
ESDG6246921Tizian Ceramic Transparent Light-Blue T76246922016-09-08
ESDG6247011Tizian Ceramic Opaquer A16247012016-09-08
ESDG6247021Tizian Ceramic Opaquer A26247022016-09-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
EBGO50525US1Mediloy Titan Grade 5 SLM PulverBEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KGEJH2026-03-24
00304040187463ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187470ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187487ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187517ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187524ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187531ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187548ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187555ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187562ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187579ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187586ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187593ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187616ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187623ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187647ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187654ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187661ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187678ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187708ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187722ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187739ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187746ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187760ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187784ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187807ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187838ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187845ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187852ZirluxHENRY SCHEIN, INC.EJH2026-02-04
00304040187869ZirluxHENRY SCHEIN, INC.EJH2026-02-04