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UltraCal XS 5145

by Ultradent Products, Inc. 2 variants

UltraCal XS 5145 is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K211905 on 13 Oct 2021 and listed in FDA GUDID since 17 Jun 2023 (UDI-DI 00883205033253), active as of 23 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 23 Oct 2026

Documents

510(k) K211905

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00883205033253 UDI-DI Date17 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK211905 Date13 Oct 2021IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211905 decided 13 Oct 2021 Active
  • FDA GUDID UDI-DI 00883205033253 listed 17 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211905
  2. Listed FDA GUDID 00883205033253

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
UltraCal XS
Generic name
Calcium hydroxide dental suspension
Model / Ref / Catalog
5145
Primary DI / UDI-DI
00883205033253
510(k) Number
FDA product code
KIF
GMDN term
Calcium hydroxide dental suspension
Device class
Class II
Regulation number
872.3820
GUDID distribution status
In Commercial Distribution

Related devices

Category: Calcium hydroxide dental suspension

Cleared under the same submission (K211905)

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)