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ceraMotion® 254-008-10

by Dentaurum

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberJ011254008100 UDI-DI Date25 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK011425 Date5 Jun 2001DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
254-008-10
Primary DI / UDI-DI
J011254008100
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)

Show all (12)

Other devices from Dentaurum

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No