Gentle Hand-Bur Systems

FDA UDI

Class I (US FDA UDI)

by Dental Care For All International

Identity

Trade Name: Gentle Hand-Bur Systems FDA UDI
Generic Name: Manual non-rotary dental instrument handle FDA UDI
Device Name: 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. FDA UDI
Model / Reference: C4 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860007700842 FDA UDI
FDA Product Code: DZN FDA UDI
GMDN Term: Manual non-rotary dental instrument handle FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual non-rotary dental instrument handle

Gentle Hand-Bur Systems by Dental Care For All International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Dental Care For All International

Sources (1)

FDA UDI af023d9d-11f5-4a57-af1f-30f56261bf3f 34 fields · synced May 30, 2026