SmarTemp X1
FDA 510(k) K190930 · Parkell, Inc.
510(k) numberK190930
Submission
- Device name
- SmarTemp X1
- Applicant
- Parkell, Inc.
Edgewood, NY, US - Received
- April 10, 2019
- Decision date
- September 5, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K261261 | Dura-ArchEBG · Traditional | Hangzhou SHINING3D Dental Technology Co., Ltd. | 04/17/2026SE |
| K253380 | FLNT Base and FLNT TempEBG · Traditional | Liaoning Upcera Co., Ltd. | 03/02/2026SE |
| K251271 | TempFIT Temporary Crown and Bridge ResinEBG · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 06/23/2025SE |
| K243370 | DentaTOOTHEBG · Traditional | Asiga Pty, Ltd. | 05/05/2025SE |
| K243621 | Evoblock, PerléonEBG · Traditional | Evoden Indústria Comércio Importação E Exportação | 04/22/2025SE |
| K243951 | TEMP MASTER, PMMA-based dental resinEBG · Traditional | Taiwan Dental Materials Co., Ltd. | 02/21/2025SE |
| K242559 | Digital TempEBG · Traditional | Sprintray, Inc. | 11/26/2024SE |
| K231859 | PrimmaArtEBG · Traditional | Dentscare Ltda | 11/26/2024SE |
| K240538 | Premium Teeth ResinEBG · Traditional | Formlabs Ohio, Inc. | 07/19/2024SE |
| K241226 | Fixtemp® C&B 4:1EBG · Special | Dreve Denatmid GmbH | 05/31/2024SE |
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| K142848 | Eazy PrimerKLE · Traditional | 02/24/2015SE |
| K132115 | Absolute Dentin 2EBF · Traditional | 06/25/2014SE |
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Questions and answers
When was SmarTemp X1 cleared by the FDA?
SmarTemp X1 (K190930) received a 510(k) decision of Substantially Equivalent on September 5, 2019, 148 days after the submission was received.
What is the product code of K190930?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.