FDA.report

Austenal®

Primary DI
D001N0412010
Brand
Austenal®
Company
Dentsply International Inc.
Model
Welding Rods
Catalog number
N041201
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
D001N0412010PrimaryHIBCC0
D001N0412018Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental soldering alloyA mixture of metals in the form of a thin rod used to solder cast dental restorations. It is a fusible alloy used to join less fusible materials (e.g., other metals, metal wires) through the application of high-temperature heat to the metal components to be joined; the soldering metal melts around the joint to create the fusion. The soldering process operates at lower termperatures than brazing. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Length12Inch

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
606173334
Device count
16
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
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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