FDA UDI Not in Commercial Distribution 🇺🇸 United States

Ivostar Gnathostar

DI: DIVO7421471 · Model: 742147 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12

Basic Information

Brand Name
Ivostar Gnathostar
Primary DI
DIVO7421471
Version / Model
742147
Catalog Number
742147
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
12
Record Status
Published
Publish Date
2021-04-19
Public Version
2
Public Version Date
2022-03-16
Public Version Status
Update
Public Device Record Key
116b5e89-956e-4f31-8cd0-2deaea9e65ef
Distribution End Date
2022-03-15

Device Description

Ivostar 6er A-D O34 A3, Ivostar 6er A-D O32 A3, Ivostar 6er A-D O03 A3, Ivostar 6er A-D U14 A3, Ivostar 6er A-D U15 A3, Ivostar 6er A-D U11 A3, Gnathostar 8er A-D OD84 A3, Gnathostar 8er A-D UD84 A3, Gnathostar 8er A-D OD88 A3, Gnathostar 8er A-D UD88 A3

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
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
Unit of Use DIVO7421470
Primary DIVO7421471