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TruMatch CMF Titanium 3D Printed Splints SD980.030

by Materialise NV

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 2 Nov 2026

Documents

510(k) K260913

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05420060351228 UDI-DI Date20 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK260913 Date9 Oct 2026DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TruMatch CMF Titanium 3D Printed Splints
Generic name
Fixed dental occlusal splint, custom-made
Model / Ref / Catalog
SD980.030
Primary DI / UDI-DI
05420060351228
510(k) Number
FDA product code
DZJ, LLZ
GMDN term
Fixed dental occlusal splint, custom-made
Device class
Class II
Regulation number
872.4120, 892.2050
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K260913)

Show all (12)

Other devices from Materialise NV

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Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date

Other properties (9)

  • Supplied sterile: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Expiration date: No