FDA UDI In Commercial Distribution 🇺🇸 United States

BIO-C TEMP

DI: 07898078659915 · Model: BIO-C TEMP 0.5 g · Angelus Industria de Produtos Odontologicos S A
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BIO-C TEMP
Primary DI
07898078659915
Version / Model
BIO-C TEMP 0.5 g
Catalog Number
2832
Company Name
Angelus Industria de Produtos Odontologicos S A
Labeler DUNS
906943303
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-11-06
Public Version
1
Public Version Date
2020-11-16
Public Version Status
New
Public Device Record Key
f1f44efa-f4b8-40e9-9503-43c4c33b4c99

Device Description

Ready-to-use Bioceramic Paste for Intracanal Dressing - BIO-C TEMP 0.5 g

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
KIF Resin, Root Canal Filling

GMDN Terms

Code Name
36095 Endodontic filling/sealing material

Identifiers

Type ID
Primary 07898078659915

Customer Contacts