FDA UDI
In Commercial Distribution
🇺🇸 United States
PM 1:1 TWIST DRILL
DI: J00716011900011
·
Model: 1601190-001
·
Bien-Air Dental SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PM 1:1 TWIST DRILL
- Primary DI
- J00716011900011
- Version / Model
- 1601190-001
- Catalog Number
- 1601190-001
- Company Name
- Bien-Air Dental SA
- Labeler DUNS
- 480082080
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-12
- Public Version
- 2
- Public Version Date
- 2023-11-13
- Public Version Status
- Update
- Public Device Record Key
- 88f55f38-337a-44e9-9c24-afa1d58e69cf
Device Description
Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor. Product intended for use in oral and maxillofacial surgery.
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34700 | Dental laboratory drilling system handpiece | A hand-held device that includes a chuck for attaching drills, burs, grind wheels, and similar rotating devices used in the dental laboratory. The device is typically remote from the power source (e.g., a dental laboratory drill motor) and is connected to this by a flexible drive system, which may be a Bowden cable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J00716011900011 | HIBCC |
Customer Contacts
- Phone
- +1 949-477-6050
- [email protected]