Quala Q055003

by National Distribution & Contracting, Inc.

Quala Q055003 is a Class II device made by National Distribution & Contracting, Inc., cleared under FDA 510(k) K820617 on 25 Mar 1982 and listed in FDA GUDID since 13 Feb 2017 (UDI-DI D023Q0550031), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD023Q0550031 UDI-DI	Date13 Feb 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK820617	Date25 Mar 1982Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K820617

Across registries

2 registries list this device

FDA 510(k) K820617 decided 25 Mar 1982 Active
FDA GUDID UDI-DI D023Q0550031 listed 13 Feb 2017 Listed

Timeline

2 dated events

25 Mar 1982 Cleared FDA 510(k) K820617
13 Feb 2017 Listed FDA GUDID D023Q0550031

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Quala
Generic name: Dental amalgam
Model / Ref / Catalog: Q055003

Primary DI / UDI-DI: D023Q0550031
510(k) Number: K820617
FDA product code: EJJ
GMDN term: Dental amalgam

Device class: Class II
Regulation number: 872.3070
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Lot / batch number
Expiration date

Other properties (12, all answered No)