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OrthoFit Splint

by Spident Co., Ltd.

OrthoFit Splint is a Class II device made by Spident Co., Ltd., cleared under FDA 510(k) K261129 on 2 Jul 2026 and listed in FDA GUDID since 14 Jul 2026 (UDI-DI 08809262957990), 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) K261129

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 Number08809262957990 UDI-DI Date14 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK261129 Date2 Jul 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K261129 decided 2 Jul 2026 Active
  • FDA GUDID UDI-DI 08809262957990 listed 14 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K261129
  2. Listed FDA GUDID 08809262957990

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
OrthoFit
Generic name
Orthodontic bracket adhesive
Model / reference
OrthoFit Splint
Primary DI / UDI-DI
08809262957990
510(k) Number
FDA product code
DYH
GMDN term
Orthodontic bracket adhesive
Device class
Class II
Regulation number
872.3750
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K261129)

Other devices from Spident Co., Ltd.

See all devices from Spident Co., Ltd. →

Properties

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