Gentle Hand-Bur Systems
GUDID 00860007700897
P4: Package of four GHB premium handles. A “P” handle (Premium-Lock handle) consists of a standard, round, threaded, aluminum handle which embodies a micro-chuck assembly (MCA) and perforated pin-locking handle. A 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, a bur-locking-wrench grips the MCA and is counter-tightened by a stainless steel locking pin at the handle’s opposite end. The “P” model MCA is ideal for users who like the flexibility of chair-side bur changing when desired, but multi-handle operation for maximum efficiency otherwise. The MCA’s outer sleeve embodies two locking grooves or slots that engage a 7 mm bur-locking “wrench” or “key.” It is made of durable, 2 mm thick, 6061-T6 medical grade aluminum. Designed for maximum strength and longevity, the MCA can withstand the demands of repeated bur-tightening common to a busy dental practice engaged in chair-side bur changing. This is why this model is classed as a “premium” model. Finally, both aluminum components, handle and MCA, are shielded from excessive friction and wear from routine tightening, by a durable, anti-friction stainless steel washer. The “P4” pack includes operational accessories. 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 team@dcfai.org or +19562801708 (same as Whatsapp number) so we can make it right, whatever we have to do.
DENTAL CARE FOR ALL INTERNATIONAL
Manual non-rotary dental instrument handle| Primary Device ID | 00860007700897 |
| NIH Device Record Key | 73096309-0cdf-4883-8b9b-5cd6db47c1c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gentle Hand-Bur Systems |
| Version Model Number | P4 |
| Company DUNS | 118270502 |
| Company Name | DENTAL CARE FOR ALL INTERNATIONAL |
| Device Count | 4 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860007700880 [Primary] |
| GS1 | 00860007700897 [Unit of Use] |
FDA Product Code
| DZN | Instruments, Dental Hand |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
[00860007700897]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-13 |
| Device Publish Date | 2022-06-05 |
On-Brand Devices [Gentle Hand-Bur Systems]
| 00860007700873 | E1: One clamp-lock non-perforated handle with standard clamp-lock collar and accessories. A clam |
| 00860007700866 | C4: Four non-perforated handles with key-lock collar handle and accessories. Learn more about ou |
| 00860007700835 | KC8H: Eight clamp-lock non-perforated handles with key-lock collar handle and accessories. Learn |
| 00860007700804 | P2: Two pin-lock perforated handles with key-lock collar and accessories. Learn more about our m |
| 00860007700897 | P4: Package of four GHB premium handles. A “P” handle (Premium-Lock handle) consists of a s |
| 00196852155521 | P1: Package of one GHB premium handle. A “P” handle (Premium-Lock handle) consists of a st |
Trademark Results [Gentle Hand-Bur Systems]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENTLE HAND-BUR SYSTEMS 97086759 not registered Live/Pending |
Beauchemin, Gerard J 2021-10-21 |
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