IA-40 H Drive Handpiece for Bredent 16834011

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	NumberJ021168340111 UDI-DI	Date12 Sep 2019Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: IA-40 H Drive Handpiece for Bredent
Generic Name: Surgical screwdriver, reusable
Model / Reference: 16834011

Primary DI / UDI-DI: J021168340111
FDA Product Code: EKX
GMDN Term: Surgical screwdriver, reusable

Device Class: Class I
Regulation Number: 872.4200
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Serial 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
Lot / Batch Number: No
Expiration Date: No