FDA.report

Dentorium

Primary DI
05056079040633
Brand
Dentorium
Company
WRIGHT HEALTH GROUP LIMITED
Model
Chrome Cobalt Neutral Ingot Extra Hard N
Catalog number
AL124
Device description
Bonding Alloy
Published
2016-10-01
Public version status
Update
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

Contact Domains

Product Codes

CodeName
EJHAlloy, Metal, Base

Product Code Classifications

CodeDeviceSpecialtyClass
EJHAlloy, Metal, BaseDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05056079040633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05056079040633050560790406335056079040633

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

Contacts

PhoneEmail
+1(800)847-4209mail@dentorium.com

Regulatory Flags

DUNS number
214045304
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

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05056079070500Dentoluxx VPosterior PE Upper B4DXVPEUB42026-02-18
05056079070517Dentoluxx VPosterior PE Upper C1DXVPEUC12026-02-18
05056079070524Dentoluxx VPosterior PE Upper C2DXVPEUC22026-02-18
05056079070531Dentoluxx VPosterior PE Upper C3DXVPEUC32026-02-18
05056079070548Dentoluxx VPosterior PE Upper C4DXVPEUC42026-02-18
05056079070555Dentoluxx VPosterior PE Upper D2DXVPEUD22026-02-18

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