Gentle Hand-Bur Systems
Basic Information
- Brand Name
- Gentle Hand-Bur Systems
- Primary DI
- 00196852155521
- Version / Model
- P1
- Company Name
- DENTAL CARE FOR ALL INTERNATIONAL
- Labeler DUNS
- 118270502
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-09
- Public Version
- 3
- Public Version Date
- 2023-03-10
- Public Version Status
- Update
- Public Device Record Key
- 30415e69-b364-4a5e-875a-2e6b83e2db46
- Distribution End Date
- 2022-10-12
Device Description
P1: Promotional Sample This model consists of a standard 1 mm micro-chuck assembly (MCA) compression collar or sleeve. The 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, any two external gripping or clamping devices are used to counter-tighten the inferior handle's main body against the superior handle's MCA. When sold in packs of 4, they are ideally suited to multi-handle, quick-switch operation. We insists on strict bur-tightening verification protocols in our instructions for use. Learn more about our mission 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 number) so we can make it right, whatever we have to do.
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 |
|---|---|---|---|---|---|---|
| Primary | 00196852155521 | GS1 |
Customer Contacts
- Phone
- +19562801708
- [email protected]