Scaler D/E Usc 3-4 Handform Handle 70-4100HF

by W.H. Holden, Inc.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD928704100HF0 UDI-DI	Date20 Dec 2023Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Scaler D/E Usc 3-4 Handform Handle
Generic Name: Manual dental scaler, reusable
Model / Reference: 70-4100HF

Primary DI / UDI-DI: D928704100HF0
FDA Product Code: EMN
GMDN Term: Manual dental scaler, reusable

Device Class: Class I
Regulation Number: 872.4565
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Premarket Exempt
Lot / Batch Number
Manufacturing Date

Other properties (11)

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