Scaler Tip 4U 05849201

by W&H Dentalwerk Burmoos

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberJ021058492011 UDI-DI	Date19 Jul 2023Listed	StatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Scaler Tip 4U
Generic Name: Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Model / Reference: 05849201

Primary DI / UDI-DI: J021058492011
FDA Product Code: ELC
GMDN Term: Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Device Class: Class II
Regulation Number: 872.4850
GUDID distribution status: Not in Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Prescription Use
Lot / Batch Number
Manufacturing Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No