OrthoFit
FDA 510(k) K261129 · Spident Co., Ltd.
510(k) numberK261129
Submission
- Device name
- OrthoFit
- Applicant
- Spident Co., Ltd.
Incheon, KR - Received
- April 6, 2026
- Decision date
- July 2, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml…KLE · Traditional | 11/01/2024SE |
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| K231523 | EsCom250EBF · Traditional | 07/24/2023SE |
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Questions and answers
When was OrthoFit cleared by the FDA?
OrthoFit (K261129) received a 510(k) decision of Substantially Equivalent on July 2, 2026, 87 days after the submission was received.
What is the product code of K261129?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.