OrthoFit— 510(k) K261129

Substantially Equivalent

Spident Co., Ltd.

FDA 510(k) clearance K261129 for OrthoFit, Substantially Equivalent on 2026-07-02. Applicant: Spident Co., Ltd.. Device class: 2.

Clearance details

Applicant: Spident Co., Ltd.
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2026-04-06
Decision date: 2026-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Incheon, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYH

K261840 — BracePaste Prime Plus2026-06-03
K250015 — Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive2025-01-03
K242537 — BracePaste Fluoride Sealant2024-08-27
K234043 — 3M Transbond Orthodontic Adhesive2023-12-22
K231817 — AlignerFlow LC2023-12-01

More clearances from Spident Co., Ltd.

K250566 — EsCem RMGI2025-06-20
K250317 — EsFlow PLUS2025-05-30
K242702 — VioSeal2024-11-07
K242675 — FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)2024-11-01
K241445 — K-Bond Universal2024-07-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.