Gentle Hand-Bur Systems
- Primary DI
- 00860007700804
- Brand
- Gentle Hand-Bur Systems
- Company
- DENTAL CARE FOR ALL INTERNATIONAL
- Model
- P2
- Device description
- "P2: A “P2” dental hand-bur handle, is a ""premium"" locking-handle which consists of a round, threaded, aluminum handle which embodies a heavy-duty micro-chuck assembly (MCA). The MCA embodies a threaded end which screws into the handle’s internal threads in order to secure a dental bur so it cannot dislodge while in use. To secure a dental bur after insertion, a bur-locking-wrench grips the MCA and is counter-tightened by a locking pin at the handle’s opposite end. The MCA’s outer sleeve embodies two locking grooves (or slots) that engage a 7 mm bur-locking “wrench” or “key.” The casing is made of durable, 2 mm 6061-T6 medical grade aluminum designed for maximum strength and longevity. Rightly classed as a “premium” model, it can withstand the demands of repeated bur-tightening common to a busy dental practice engaged in chair-side bur changing. Learn more about our mission at dentalcareforall.org. If you have any complaints with our products please call or email us for immediate resolution: email team@dcfai.org / Call +19562801708 (WhatsApp)"
- Published
- 2022-03-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| DZN | Instruments, Dental Hand |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00860007700804 | Primary | GS1 | 0 | |
| 00860007700828 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00860007700804 | 00860007700804 | 860007700804 | 0860007700804 |
| 00860007700828 | 00860007700828 | 860007700828 | 0860007700828 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +9562801708 | team@gentlehandburs.com |
Regulatory Flags#
- DUNS number
- 118270502
- Device count
- 2
- Premarket exempt
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00860007700842 | Gentle Hand-Bur Systems | C4 | 2022-03-24 | |
| 00860007700811 | Gentle Hand-Bur Systems | KC | 2022-03-24 | |
| 00860007700880 | Gentle Hand-Bur Systems | P4 | 2022-06-05 | |
| 00196852155521 | Gentle Hand-Bur Systems | P1 | 2022-07-09 | |
| 00860007700873 | Gentle Hand-Bur Systems | E1 | 2022-03-24 | |
| 00860007700897 | Gentle Hand-Bur Systems | P4 | 2022-06-05 | |
| 00860007700835 | Gentle Hand-Bur Systems | KC | 2022-03-24 | |
| 00860007700866 | Gentle Hand-Bur Systems | C4 | 2022-03-24 |
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