FDA UDI In Commercial Distribution 🇺🇸 United States

Vertex-Dental BV

DI: 08719425508955 · Model: NDCMN1.501000_1 · Vertex-Dental B.V.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Vertex-Dental BV
Primary DI
08719425508955
Version / Model
NDCMN1.501000_1
Company Name
Vertex-Dental B.V.
Labeler DUNS
406389056
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-08-03
Public Version
1
Public Version Date
2023-08-11
Public Version Status
New
Public Device Record Key
448ba068-3577-451e-a1c2-8fb17dc7b7d3

Device Description

For manufacturing 3d printed crowns and bridges

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ELJ TEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT
ELK TEETH, ARTIFICIAL, BACKING AND FACING

GMDN Terms

Code Name
45236 Temporary dental crown/bridge resin

Identifiers

Type ID
Primary 08719425508955