FDA UDI In Commercial Distribution 🇺🇸 United States

SPHERICAL AMALGAM

DI: D74422905950 · Model: 2290-595 · BENCO DENTAL SUPPLY CO.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
SPHERICAL AMALGAM
Primary DI
D74422905950
Version / Model
2290-595
Company Name
BENCO DENTAL SUPPLY CO.
Labeler DUNS
015108087
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-02-13
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
db0585a5-4195-4d68-a75b-90fe10e68db4

Device Description

EON ORIG SPHERICAL #2 FAST 500

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EJJ Alloy, Amalgam

GMDN Terms

Code Name
34836 Dental amalgam alloy

Identifiers

Type ID
Primary D74422905950

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
0 – 25 Degrees Celsius