Gentle Hand-Bur Systems
Basic Information
- Brand Name
- Gentle Hand-Bur Systems
- Primary DI
- 00860007700842
- Version / Model
- C4
- Company Name
- DENTAL CARE FOR ALL INTERNATIONAL
- Labeler DUNS
- 118270502
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2022-03-24
- Public Version
- 9
- Public Version Date
- 2023-11-07
- Public Version Status
- Update
- Public Device Record Key
- af023d9d-11f5-4a57-af1f-30f56261bf3f
Device Description
C4 dental bur handles are pen-style, pin vise (PSPV) aluminum handles normally used in sets of four. They securely anchor 2 mm diameter burs for "Quick-Swith" operation. Our PSPV model was originally designed to anchor surgical blades with the twisting power of direct hand force only. This model has endured the test of time, having served humanity over 90 years. For greater operator assurance in dental use, in addition to standard procedure bur-security monitoring, DCFAI requires supplemental mechanical clamping force (MCF) on its external compression collar. This enables maximum anchoring force on the handle's knurled surface as it is fully and firmly gripped by the operator's dominant hand. An exception to MCF extends to users of long-stem burs who have adopted bur-shaft / finger-grip operation. Our PSPV model is not proprietary; they are globally available online. Learn about our mission at dentalcareforall.org. We urge anyone, with any complaints concerning our bur-handles, to call or email us for immediate resolution: +19562801708 (WhatsAp); [email protected]
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00860007700866 | GS1 | ||||
| Primary | 00860007700842 | GS1 |
Customer Contacts
- Phone
- +9562801708
- [email protected]