FDA UDI In Commercial Distribution 🇺🇸 United States

PORTUX CAD/CAM Disc. 98.5X 25mm B3. MN

DI: 07701126712121 · Model: 0023317 · PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PORTUX CAD/CAM Disc. 98.5X 25mm B3. MN
Primary DI
07701126712121
Version / Model
0023317
Catalog Number
0023317
Company Name
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
Labeler DUNS
880141023
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-03-07
Public Version
1
Public Version Date
2024-03-15
Public Version Status
New
Public Device Record Key
b9dbf8b0-ed8f-4a76-8629-c40e58d31355

Device Description

PORTUX CAD/CAM Disc. 98.5X 25mm B3. MN

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
Yes
Has Expiration Date
Yes
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
45236 Temporary dental crown/bridge resin

Identifiers

Type ID
Primary 07701126712121

Premarket Submissions

Submission Number Supplement Number
K192153 000