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Calciject 320003

by Centrix, Inc.

Calciject 320003 is a Class II device made by Centrix, Inc., cleared under FDA 510(k) K001050 on 21 Jul 2000 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00817051020822), 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

510(k) K001050

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817051020822 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK001050 Date21 Jul 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K001050 decided 21 Jul 2000 Active
  • FDA GUDID UDI-DI 00817051020822 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K001050
  2. Listed FDA GUDID 00817051020822

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Calciject
Generic name
Calcium hydroxide dental suspension
Model / reference
320003
Primary DI / UDI-DI
00817051020822
510(k) Number
FDA product code
EJK
GMDN term
Calcium hydroxide dental suspension
Device class
Class II
Regulation number
872.3250
GUDID distribution status
In Commercial Distribution

Related devices

Category: Calcium hydroxide dental suspension

Other devices from Centrix, Inc.

See all devices from Centrix, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)