Gentle Hand-Bur Systems
Basic Information
- Brand Name
- Gentle Hand-Bur Systems
- Primary DI
- 00860007700811
- Version / Model
- KC
- Company Name
- DENTAL CARE FOR ALL INTERNATIONAL
- Labeler DUNS
- 118270502
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2022-03-24
- Public Version
- 3
- Public Version Date
- 2022-05-25
- Public Version Status
- Update
- Public Device Record Key
- a981b97d-43ae-4a46-af64-03de6d91d70d
Device Description
The KC handle is a light duty, economical handle ideally suited for maximum efficiency eight-handle, back-to-back patient appointments. The handle is perforated for pin-lock counter-tightening against an micro-chuck assembly (MCA) non-marring clamping device. Precision, pin-lock tightening, inherently minimizes over-tightening of the KC’s light-duty MCA along with the infrequent tightening of multi-handle operation which also prolongs the MCA’s service life. Both the handle and the MCA are shielded when tightening by a durable, anti-friction, anti-wear stainless steel washer. This model’s clamp-lock MCA and pin-lock handle firmly secures a dental bur so it cannot dislodge; pack includes operational accessories. Learn more at dentalcareforall.org. If anyone has any complaints with our hand-burs, we ask that they please email or call us at [email protected] or +19562801708 (same as Whatsapp #) so we can promptly make it right.
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 | 00860007700835 | GS1 | ||||
| Primary | 00860007700811 | GS1 |