FDA.report

GIALLOY CB/N-H

Primary DI
ESRL58903501
Brand
GIALLOY CB/N-H
Company
SRL Dental GmbH
Model
5890350 Bedruckt SRL 25kg Eimer
Device description
Aufbrennfähige Nichtedelmetall-Dental-Gusslegierung auf Nickel-Basis, Typ 4 / NPM Nickel-based dental alloy for casting, type 4 Bedruckt SRL 25 kg Eimer
Published
2018-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EJHAlloy, Metal, Base

Product Code Classifications

CodeDeviceSpecialtyClass
EJHAlloy, Metal, BaseDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESRL58903501PrimaryHIBCC0

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
313446764
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
ESRL58900021GIALLOY PA 5890002 neutral 12 x 1 kg2018-11-08
ESRL58900511GIALLOY PA 5890051 Neutral 25 kg Eimer2018-11-08
ESRL58900551GIALLOY PA 5890055 China 25 kg Eimer2018-11-08
ESRL58900811GIALLOY PA 5890081 bedruckt SRL 1 kg Dose2018-11-08
ESRL58901011GIALLOY CB 5890101 bedruckt SRL 12 x 1 kg2018-11-08
ESRL58901021GIALLOY CB5890102 Neutral 12 x 1 kg2018-11-08
ESRL58901501GIALLOY CB5890150 bedruckt SRL 25 kg Eimer2018-11-08
ESRL58901511GIALLOY CB5890151 Neutral 25 kg Eimer2018-11-08
ESRL58901561GIALLOY CB 5890156 Bedruckt China 25 kg Eimer2018-11-08
ESRL58904991GIALLOY CB-H5890499 Bedruckt 50 g Muster2018-11-08
ESRL58951211GIALLOY CB BLANK5895121 Gestuft SRL 12 mm 10 St.2018-11-07
ESRL58900011GIALLOY PA 5890001 bedruckt 12 x 1 kg2018-11-06
ESRL58901801GIALLOY CB5890180 bedruckt SRL 1 kg Dose 2018-11-06
ESRL58901991GIALLOY CB5890199 bedruckt 50 g Muster2018-11-06
ESRL58902011GIALLOY CB/N5890201 Bedruckt SRL 12 x 1 kg2018-11-06
ESRL58902021GIALLOY CB/N5890202 Neutral 12 x 1 kg 2018-11-06
ESRL58902501GIALLOY CB/N5890250 Bedruckt SRL 25 kg/Eimer2018-11-06
ESRL58902511GIALLOY CB/N5890251 Neutral 25 kg Eimer2018-11-06
ESRL58902581GIALLOY CB/N5890258 China 25 kg Eimer2018-11-06
ESRL58902801GIALLOY CB/N5890280 Neutral 10 x 1 kg Dose2018-11-06

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