FDA.report

Austenal®

Primary DI
D001N7576550
Brand
Austenal®
Company
Dentsply International Inc.
Model
NCM Alpha™
Catalog number
N757655
Published
2017-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EJHALLOY, METAL, BASE

Product Code Classifications

CodeDeviceSpecialtyClass
EJHAlloy, Metal, BaseDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D001N7576550PrimaryHIBCC0

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.

Device Sizes

TypeValueUnit
Weight155.5Gram

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)243-1942Prosthetics-Regulatory@dentsplysirona.com

Regulatory Flags

DUNS number
606173334
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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