Gentle Hand-Bur Systems
GUDID 00860007700873
E1: One clamp-lock non-perforated handle with standard clamp-lock collar and accessories. A clamp-lock handle and collar refers to a handle and collar which uses a mechanical gripping device to firmly anchor (lock) a dental bur in place so it cannot dislodge. Learn more 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 | 00860007700873 |
| NIH Device Record Key | 0279a15d-0969-4830-a48d-864ce92106e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gentle Hand-Bur Systems |
| Version Model Number | E1 |
| Company DUNS | 118270502 |
| Company Name | DENTAL CARE FOR ALL INTERNATIONAL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | 00860007700873 [Primary] |
FDA Product Code
| DZN | Instruments, Dental Hand |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
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[00860007700873]
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Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-01 |
| Device Publish Date | 2022-03-24 |
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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