EsCom250
FDA 510(k) K231523 · Spident Co., Ltd.
510(k) numberK231523
Submission
- Device name
- EsCom250
- Applicant
- Spident Co., Ltd.
Incheon, KR - Received
- May 26, 2023
- Decision date
- July 24, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K242702 | VioSealKIF · Traditional | 11/07/2024SE |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml…KLE · Traditional | 11/01/2024SE |
| K241445 | K-Bond UniversalKLE · Traditional | 07/22/2024SE |
| K214076 | EsCemEMA · Traditional | 12/19/2022SE |
| K214071 | Hexa-TempEBG · Traditional | 03/10/2022SE |
| K161774 | i-SilELW · Traditional | 09/30/2016SE |
Questions and answers
When was EsCom250 cleared by the FDA?
EsCom250 (K231523) received a 510(k) decision of Substantially Equivalent on July 24, 2023, 59 days after the submission was received.
What is the product code of K231523?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.