FDA UDI
In Commercial Distribution
🇺🇸 United States
CA 20:1 LKM Micro-Series
DI: J00716008740011
·
Model: 1600874-001
·
Bien-Air Dental SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CA 20:1 LKM Micro-Series
- Primary DI
- J00716008740011
- Version / Model
- 1600874-001
- Catalog Number
- 1600874-001
- 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
- 3
- Public Version Date
- 2023-07-17
- Public Version Status
- Update
- Public Device Record Key
- 7e75fda6-8599-4149-b446-14e8081176eb
Device Description
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
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 | J00716008740011 | HIBCC |
Customer Contacts
- Phone
- +1 949-477-6050
- [email protected]