FDA UDI In Commercial Distribution 🇺🇸 United States

Resin Teeth DCL PE

DI: DIVO5402421 · Model: 540242 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Resin Teeth DCL PE
Primary DI
DIVO5402421
Version / Model
540242
Catalog Number
540242
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-01-23
Public Version
1
Public Version Date
2019-02-25
Public Version Status
New
Public Device Record Key
935ccebd-e00b-429f-a421-944105dc2af5

Device Description

SR Orthotyp 8er ON3 540

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 DIVO5402421