FDA UDI In Commercial Distribution 🇺🇸 United States

ANAXDENT PMMA

DI: 08435288495132 · Model: U MULTIBLANK A3,5 98,5/20mm · UNION DENTAL SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ANAXDENT PMMA
Primary DI
08435288495132
Version / Model
U MULTIBLANK A3,5 98,5/20mm
Catalog Number
18121420
Company Name
UNION DENTAL SA
Labeler DUNS
462114760
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-10-06
Public Version
2
Public Version Date
2021-10-29
Public Version Status
Update
Public Device Record Key
049dc7e0-240a-4f1c-acbd-c7ba3cbdaf27

Device Description

ANAXDENT PMMA DISC U MULTIBLANK COLOR A3,5 98,5/20mm

Device Characteristics

Single Use
No
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EBG Crown And Bridge, Temporary, Resin

GMDN Terms

Code Name
31783 Temporary dental crown/bridge

Identifiers

Type ID
Primary 08435288495132

Premarket Submissions

Submission Number Supplement Number
K150432 000