FDA UDI In Commercial Distribution 🇺🇸 United States

TUFF-TEMP PLUS

DI: D701TTP50A2X2 · Model: TTP50A2X · PULPDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TUFF-TEMP PLUS
Primary DI
D701TTP50A2X2
Version / Model
TTP50A2X
Company Name
PULPDENT CORPORATION
Labeler DUNS
001006089
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-11-22
Public Version
2
Public Version Date
2021-10-29
Public Version Status
Update
Public Device Record Key
5dad84e2-de53-459b-808b-c742bbe1ea30

Device Description

TUFF-TEMP PLUS 50ML A2 SHADE 50ml CARTRIDGE ONLY

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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EBG Crown And Bridge, Temporary, Resin

GMDN Terms

Code Name
45236 Temporary dental crown/bridge resin

Identifiers

Type ID
Primary D701TTP50A2X2