FDA UDI Not in Commercial Distribution 🇺🇸 United States

Ivostar Gnathostar

DI: DIVO5171081 · Model: 517108 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ivostar Gnathostar
Primary DI
DIVO5171081
Version / Model
517108
Catalog Number
517108
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-01-22
Public Version
2
Public Version Date
2023-08-21
Public Version Status
Update
Public Device Record Key
8d305004-a933-44a6-8f29-13d544f40b57
Distribution End Date
2023-08-18

Device Description

Gnathostar Set of 8 UD88 4B

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
ELM Denture, plastic, teeth

GMDN Terms

Code Name
38643 Resin artificial teeth

Identifiers

Type ID
Primary DIVO5171081