Gentle Hand-Bur Systems
Basic Information
- Brand Name
- Gentle Hand-Bur Systems
- Primary DI
- 00860007700804
- Version / Model
- P2
- Company Name
- DENTAL CARE FOR ALL INTERNATIONAL
- Labeler DUNS
- 118270502
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2022-03-24
- Public Version
- 4
- Public Version Date
- 2023-05-15
- Public Version Status
- Update
- Public Device Record Key
- 176c185a-0b0c-4dac-ad99-afbaf956ab95
Device Description
A “P” dental hand-bur handle (Premium-Lock handle) consists of a standard, round, threaded, aluminum handle which embodies a micro-chuck assembly (MCA) and perforated pin-locking handle. A 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 dental bur after insertion, a bur-locking-wrench grips the MCA and is counter-tightened by a stainless steel locking pin at the handle’s opposite end. The “P” model MCA is ideal for users who want both the flexibility of chair-side bur changing and multi-handle operation for maximum efficiency. The MCA’s outer sleeve embodies two locking grooves (or slots) that engage a 7 mm bur-locking “wrench” or “key.” The MCA casing is made of durable, 2 mm thick, 6061-T6 medical grade aluminum. Designed for maximum strength and longevity, the MCA can withstand the demands of repeated bur-tightening common to a busy dental practice engaged in chair-side bur changing. This is why this model is classed as a “premium” model. The “P2” pack includes operational accessories. Learn more about our mission at dentalcareforall.org. If anyone has any complaints with our dental hand-bur handles, we ask that they please email or call us for immediate resolution: email [email protected] / Call +19562801708 (WA and cell)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| 35811 | Dental excavator, reusable | A hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860007700804 | GS1 | ||||
| Unit of Use | 00860007700828 | GS1 |
Customer Contacts
- Phone
- +9562801708
- [email protected]