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.
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
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZN
Product Code Name
Instruments, Dental Hand
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 5 |