FDA.report

EL-FORM Brightener, 50 ml

Primary DI
ESDG6250210
Brand
EL-FORM Brightener, 50 ml
Company
Schütz Dental GmbH
Model
625021
Device description
Brightener for classic EL-Form Galvano system, for activation of the Galvano bath and to achieve an even build-up of coats.
Published
2016-12-08
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
EJTAlloy, Gold-Based Noble Metal

Product Code Classifications

CodeDeviceSpecialtyClass
EJTAlloy, Gold-Based Noble MetalDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESDG6250210PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental casting noble alloyA material composed primarily of noble metals [e.g., gold (Au), palladium (Pd), platinum (Pt), or silver (Ag)] 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
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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