Gentle Hand-Bur Systems
Basic Information
- Brand Name
- Gentle Hand-Bur Systems
- Primary DI
- 00860007700880
- Version / Model
- P4
- 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
- 2022-06-05
- Public Version
- 2
- Public Version Date
- 2023-07-07
- Public Version Status
- Update
- Public Device Record Key
- 73096309-0cdf-4883-8b9b-5cd6db47c1c7
Device Description
Four premium (P4) stainless steel Quick Switch operation (QSO) "cone-socket mirror" handles. Each handle permanently anchors an HP (straight handpiece) dental bur (44.5mm length x 2mm diameter stem). These are HP carbide (round) burs sizes #2-#4-#6-#8. Our durable handles securely anchor four dental burs with high-strength epoxy, creating a secure bond which extends throughout a bur's entire service life. Only at bur replacement time are burs quickly loosened with small vice-grips removing the old epoxy with provided tool and replacing with new. Once cured burs are tested with mechanical pull and twists test assuring operators of a 100% reliable bond. Learn more about our mission at dentalcareforall.org. If anyone has any complaints with our Gentle Hand-Burs, 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 |
|---|---|---|---|---|
| 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 | 00860007700897 | GS1 | ||||
| Primary | 00860007700880 | GS1 |
Customer Contacts
- Phone
- 19562801708
- [email protected]