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ceraMotion® 254-001-10

by Dentaurum

ceraMotion® 254-001-10 is a Class II device made by Dentaurum, cleared under FDA 510(k) K011425 on 5 Jun 2001 and listed in FDA GUDID since 25 Jul 2026 (UDI-DI J011254001100), 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) K011425

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 NumberJ011254001100 UDI-DI Date25 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK011425 Date5 Jun 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011425 decided 5 Jun 2001 Active
  • FDA GUDID UDI-DI J011254001100 listed 25 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K011425
  2. Listed FDA GUDID J011254001100

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ceraMotion®
Generic name
Dental appliance fabrication material, ceramic
Model / reference
254-001-10
Primary DI / UDI-DI
J011254001100
510(k) Number
FDA product code
EIH
GMDN term
Dental appliance fabrication material, ceramic
Device class
Class II
Regulation number
872.6660
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K011425)

and 8 more cleared under K011425

Other devices from Dentaurum

See all devices from Dentaurum →

Properties

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