FDA UDI In Commercial Distribution 🇺🇸 United States

Set Aquilon830 SR + Unifix 3H

DI: J00717002120011 · Model: 1700212-001 · Bien-Air Dental SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Set Aquilon830 SR + Unifix 3H
Primary DI
J00717002120011
Version / Model
1700212-001
Catalog Number
1700212-001
Company Name
Bien-Air Dental SA
Labeler DUNS
480082080
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-06-17
Public Version
2
Public Version Date
2021-06-29
Public Version Status
Update
Public Device Record Key
43083dd1-a596-4e94-88db-d83ac2204752

Device Description

Set of micromotor and Accessory connects micro-motors to the console

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EFB Handpiece, air-powered, dental

GMDN Terms

Code Name
40958 Dental power tool system handpiece, pneumatic

Identifiers

Type ID
Primary J00717002120011

Customer Contacts