Instrument B2R 06958600

by W&H Dentalwerk Burmoos

Listed FDA GUDID listing, no authorization on record

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	NumberJ021069586001 UDI-DI	Date18 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Instrument B2R
Generic Name: Dental ultrasonic surgical system handpiece tip
Model / Reference: 06958600

Primary DI / UDI-DI: J021069586001
FDA Product Code: DZI, ELC
GMDN Term: Dental ultrasonic surgical system handpiece tip

Device Class: Class II
Regulation Number: 872.4120, 872.4850
GUDID distribution status: 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