FDA UDI In Commercial Distribution 🇺🇸 United States

Celtra Ceram

DI: D0016502021 · Model: 650202 · Dentsply International Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Celtra Ceram
Primary DI
D0016502021
Version / Model
650202
Catalog Number
650202
Company Name
Dentsply International Inc.
Labeler DUNS
606173334
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-10-16
Public Version
2
Public Version Date
2024-11-18
Public Version Status
Update
Public Device Record Key
e05c2cdc-596e-461a-93ae-92c224a7f889

Device Description

Celtra Ceram Enamel - E2, Light, 50G

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
EIH POWDER, PORCELAIN

GMDN Terms

Code Name
16187 Dental appliance fabrication material, ceramic

Identifiers

Type ID
Primary D0016502021