Gentle Hand-Bur Systems - The KC handle is a light duty, economical handle - DENTAL CARE FOR ALL INTERNATIONAL

Duns Number:118270502

Device Description: The KC handle is a light duty, economical handle ideally suited for maximum efficiency ei The KC handle is a light duty, economical handle ideally suited for maximum efficiency eight-handle, back-to-back patient appointments. The handle is perforated for pin-lock counter-tightening against an micro-chuck assembly (MCA) non-marring clamping device. Precision, pin-lock tightening, inherently minimizes over-tightening of the KC’s light-duty MCA along with the infrequent tightening of multi-handle operation which also prolongs the MCA’s service life. Both the handle and the MCA are shielded when tightening by a durable, anti-friction, anti-wear stainless steel washer. This model’s clamp-lock MCA and pin-lock handle firmly secures a dental bur so it cannot dislodge; pack includes operational accessories. 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 #) so we can promptly make it right.

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More Product Details

Catalog Number

-

Brand Name

Gentle Hand-Bur Systems

Version/Model Number

KC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DZN

Product Code Name

Instruments, Dental Hand

Device Record Status

Public Device Record Key

a981b97d-43ae-4a46-af64-03de6d91d70d

Public Version Date

May 25, 2022

Public Version Number

3

DI Record Publish Date

March 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTAL CARE FOR ALL INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5