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UltraCal XS 1027

by Ultradent Products, Inc.

UltraCal XS 1027 is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K970114 on 14 Mar 1997 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205103970), 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) K970114

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 Number00883205103970 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK970114 Date14 Mar 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K970114 decided 14 Mar 1997 Active
  • FDA GUDID UDI-DI 00883205103970 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K970114
  2. Listed FDA GUDID 00883205103970

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  • Withdrawn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
1027
Primary DI / UDI-DI
00883205103970
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

Cleared under the same submission (K970114)

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)