FDA UDI Not in Commercial Distribution 🇺🇸 United States

ANAXDENT PMMA BLANK

DI: 08435288418179 · Model: PMMA MULTI Blank AG AB 20mm · UNION DENTAL SA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ANAXDENT PMMA BLANK
Primary DI
08435288418179
Version / Model
PMMA MULTI Blank AG AB 20mm
Catalog Number
18220220
Company Name
UNION DENTAL SA
Labeler DUNS
462114760
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-03-28
Public Version
3
Public Version Date
2023-12-25
Public Version Status
Update
Public Device Record Key
bf8dd744-168f-49b4-a2fb-b8980a690e21
Distribution End Date
2023-12-22

Device Description

ANAXDENT PMMA MULTI BLANK AG AB 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
EBI Resin, Denture, Relining, Repairing, Rebasing
EBG Crown And Bridge, Temporary, Resin

GMDN Terms

Code Name
31783 Temporary dental crown/bridge

Identifiers

Type ID
Primary 08435288418179

Premarket Submissions

Submission Number Supplement Number
K150432 000