Estemp Ne
FDA 510(k) K100290 · Spident Co., Ltd.
510(k) numberK100290
Submission
- Device name
- Estemp Ne
- Applicant
- Spident Co., Ltd.
Incheon, KR - Received
- February 2, 2010
- Decision date
- February 17, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code EMA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254201 | Any-CemEMA · Traditional | Mediclus Co., Ltd. | 08/13/2026SE |
| K261937 | PacTemp Automix NEEMA · Traditional | The Belport Company Inc., DBA Gingi-Pak | 08/07/2026SE |
| K261166 | Dia-CemEMA · Traditional | DiaDent Group International | 07/09/2026SE |
| K254109 | G-Cem UniversalEMA · Traditional | GC America, Inc. | 05/18/2026SE |
| K253337 | REGEN Bioactive CementEMA · Traditional | Inter-Med, Inc. | 04/15/2026SE |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-InEMA · Traditional | Voco GmbH | 03/20/2026SE |
| K254063 | iCEM Universal PlusEMA · Abbreviated | Kulzer, LLC | 12/19/2025SE |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin CementEMA · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/12/2025SE |
| K252808 | GlasIonomer FX-LCEMA · Traditional | Shofu Dental Corporation | 12/09/2025SE |
| K252165 | Zirconomer PEMA · Traditional | Shofu Dental Corporation | 10/28/2025SE |
More from Shofu Dental Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K262050 | Vioseal XKIF · Traditional | 09/11/2026SE |
| K261129 | OrthoFitDYH · Traditional | 07/02/2026SE |
| K250566 | EsCem RMGIEMA · Traditional | 06/20/2025SE |
| K250317 | EsFlow PLUSEBF · Traditional | 05/30/2025SE |
| 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 |
| K231523 | EsCom250EBF · Traditional | 07/24/2023SE |
| K214076 | EsCemEMA · Traditional | 12/19/2022SE |
| K214071 | Hexa-TempEBG · Traditional | 03/10/2022SE |
Questions and answers
When was Estemp Ne cleared by the FDA?
Estemp Ne (K100290) received a 510(k) decision of Substantially Equivalent on February 17, 2010, 15 days after the submission was received.
What is the product code of K100290?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.