FDA UDI In Commercial Distribution 🇺🇸 United States

BONASIL A+ Alginate Free

DI: 05206569000252 · Model: 50ml · DMP DENTAL INDUSTRY S.A.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1

Basic Information

Brand Name
BONASIL A+ Alginate Free
Primary DI
05206569000252
Version / Model
50ml
Company Name
DMP DENTAL INDUSTRY S.A.
Labeler DUNS
728534814
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
3
Public Version Date
2020-07-23
Public Version Status
Update
Public Device Record Key
3c5dee62-32c9-4af8-971a-39d004fb2a86

Device Description

Addition curing silicone impression material suitable for alginate applications

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
ELW Material, Impression

GMDN Terms

Code Name
35866 Silicone dental impression material

Identifiers

Type ID
Package 05206569470031
Primary 05206569000252
Package 05206569470024
Package 05206569001600

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
10 – 25 Degrees Celsius