AccessGUDID - DEVICE: Gentle Hand-Bur Systems (00860007700842)

GUDID

Device Identifier (DI) Information

Brand Name: Gentle Hand-Bur Systems
Version or Model: C4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DENTAL CARE FOR ALL INTERNATIONAL

Primary DI Number: 00860007700842
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 118270502 *Terms of Use

Device Description: C4: Our clamp-lock system (ideally) uses a tray-set of 4 handles with bur sizes #2,4,6,8. These pen-style, pin vise (PSPV) aluminum handles securely anchor 2 mm in diameter HP 44.5 mm dental burs. Perforated "Pin-Lock" handles twist-tighten (with a locking-pin) a micro-chuck assembly (MCA) bur-anchoring mechanism. The MCA is coupled with a smooth grip clamp-lock tightening device which grips the MCA's outer collar (compression sleeve) for counter pressure tightening with the locking pin. Testing has proven that supplemental mechanical force makes it impossible for a bur to loosen while in use.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64304	Manual non-rotary dental instrument handle	A hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	Instruments, Dental Hand

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: af023d9d-11f5-4a57-af1f-30f56261bf3f
Public Version Date: November 28, 2024
Public Version Number: 11
DI Record Publish Date: March 24, 2022