Abro Basic Mono Bleach 98H16 with step DSAL98S16BLE

by Zirkonzahn GmbH

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	NumberD800DSAL98S16BLE0 UDI-DI	Date29 Sep 2023Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Abro Basic Mono Bleach 98H16 with step
Generic Name: Dental bridge, polymer
Model / Reference: DSAL98S16BLE

Primary DI / UDI-DI: D800DSAL98S16BLE0
FDA Product Code: EBI
GMDN Term: Dental bridge, polymer

Device Class: Class II
Regulation Number: 872.3760
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (10)

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