Gentle Hand-Bur Systems - C4: Package of four GHB standard handles. A “C” - DENTAL CARE FOR ALL INTERNATIONAL

Duns Number:118270502

Device Description: C4: Package of four GHB standard handles. A “C” handle (clamp-lock standard handle) consis C4: Package of four GHB standard handles. A “C” handle (clamp-lock standard handle) consists of a standard, round, threaded, aluminum handle which embodies a standard 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 non-marring clamp grips the MCA and is counter-tightened by a stainless steel locking pin at the handle’s opposite end. The “C” model MCA is ideal for multi-handle operation—for users not interested in chair-side bur changing. Pin-lock tightening offers greater precision in minimizing over-tightening (or stressing) a standard MCA’s light-duty compression sleeve. Plus, multi-handle operation requires only infrequent tightening—limited to bur replacement, thus further prolonging a MCA’s service life. The “C4” 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.

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More Product Details

Catalog Number

-

Brand Name

Gentle Hand-Bur Systems

Version/Model Number

C4

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

af023d9d-11f5-4a57-af1f-30f56261bf3f

Public Version Date

September 20, 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