Duns Number:118270502
Device Description: P1: Package of one GHB premium handle. A “P” handle (Premium-Lock handle) consists of a s P1: Package of one GHB premium handle. A “P” handle (Premium-Lock handle) consists of a standard, round, threaded, aluminum handle which embodies a 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 bur-locking-wrench grips the MCA and is counter-tightened by a stainless steel locking pin at the handle’s opposite end. The “P” model MCA is ideal for users who want both the flexibility of chair-side bur changing and multi-handle operation for maximum efficiency. The MCA’s outer sleeve embodies two locking grooves (or slots) that engage a 7 mm bur-locking “wrench” or “key.” The MCA casing is made of durable, 2 mm thick, 6061-T6 medical grade aluminum. Designed for maximum strength and longevity, the MCA can withstand the demands of repeated bur-tightening common to a busy dental practice engaged in chair-side bur changing. This is why this model is classed as a “premium” model. The “P1” 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
P1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 12, 2022
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"
-
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
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
30415e69-b364-4a5e-875a-2e6b83e2db46
Public Version Date
October 14, 2022
Public Version Number
2
DI Record Publish Date
July 09, 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 |