FDA UDI
In Commercial Distribution
🇺🇸 United States
Gentle Hand-Bur Systems
DI: 00860007700873
·
Model: E1
·
DENTAL CARE FOR ALL INTERNATIONAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gentle Hand-Bur Systems
- Primary DI
- 00860007700873
- Version / Model
- E1
- Company Name
- DENTAL CARE FOR ALL INTERNATIONAL
- Labeler DUNS
- 118270502
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-24
- Public Version
- 11
- Public Version Date
- 2023-11-07
- Public Version Status
- Update
- Public Device Record Key
- 0279a15d-0969-4830-a48d-864ce92106e4
Device Description
E1 "All-In-One" model consists of a round, threaded, aluminum handle which embodies a micro-chuck assembly (MCA). The MCA embodies a threaded end which screws into the handle’s internal threads in order to secure a dental cutting bur so it cannot dislodge. To secure a bur after insertion, a lock-key wrench slips into the MCA's grooved collar and is counter-tightened by a firm hand-grip on the main handle's knurled area. The MCA casing consists of 2 mm thick 6061-T6 medical grade aluminum for maximum strength and longevity. Learn more about our mission at dentalcareforall.org. If anyone has any complaints with our Gentle Hand-Burs, we ask that they email or call us for immediate resolution: [email protected] / call +19562801708
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64304 | Manual non-rotary dental instrument handle | A hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860007700873 | GS1 |
Customer Contacts
- Phone
- +19562801708
- [email protected]