FDA UDI In Commercial Distribution 🇺🇸 United States

Dentivera Milling Disc

DI: 00850287007007 · Model: A001 · SOLVAY SPECIALTY POLYMERS USA, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Dentivera Milling Disc
Primary DI
00850287007007
Version / Model
A001
Catalog Number
15
Company Name
SOLVAY SPECIALTY POLYMERS USA, L.L.C.
Labeler DUNS
094731705
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-10-04
Public Version
1
Public Version Date
2018-11-05
Public Version Status
New
Public Device Record Key
e9e740f4-b303-41fd-8545-f48f2d41a3cf

Device Description

Dentivera 18mm Disc, White A1 Shade

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
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EBI Resin, Denture, Relining, Repairing, Rebasing

GMDN Terms

Code Name
58288 Dental appliance fabrication material, thermoplastic

Identifiers

Type ID
Primary 00850287007007