Gentle Hand-Bur Systems

GUDID 00860007700835

KC8H: Eight clamp-lock non-perforated handles with key-lock collar handle and 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: 00860007700835
• NIH Device Record Key: a981b97d-43ae-4a46-af64-03de6d91d70d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gentle Hand-Bur Systems
• Version Model Number: KC
• Company DUNS: 118270502
• Company Name: DENTAL CARE FOR ALL INTERNATIONAL
• Device Count: 8
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007700811 [Primary]
GS1	00860007700835 [Unit of Use]

FDA Product Code

• DZN: Instruments, Dental Hand

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

[00860007700835]

Moist Heat or Steam Sterilization

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