FDA UDI In Commercial Distribution 🇺🇸 United States

Resin Teeth / DCL / PE

DI: 07615208393873 · Model: 565917 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Resin Teeth / DCL / PE
Primary DI
07615208393873
Version / Model
565917
Catalog Number
565917
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-02-08
Public Version
1
Public Version Date
2023-02-16
Public Version Status
New
Public Device Record Key
d56ecf86-d4ab-4f4b-99a9-89d90b78c5f7

Device Description

SR Orthoplane DCL Set of 8 UMU5 C4

Device Characteristics

Single Use
Yes
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
Previous DIVO5659171
Primary 07615208393873