Alginate Impression Material
FDA 510(k) K003426 · Rite-Dent Manufacturing Corp.
510(k) numberK003426
Submission
- Device name
- Alginate Impression Material
- Applicant
- Rite-Dent Manufacturing Corp.
Hialeah, FL, US - Received
- November 3, 2000
- Decision date
- January 23, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| K254112 | Dia-X Sil BiteELW · Traditional | DiaDent Group International | 03/19/2026SE |
| K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set -…ELW · Traditional | Vigodent Indústria E Comercio Ltda | 10/31/2025SE |
| K250969 | Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastELW · Abbreviated | Dent4you AG | 06/27/2025SE |
| K241924 | Elastic Impression MaterialELW · Abbreviated | Beijing Okvd Biological Technology , Ltd. | 12/27/2024SE |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal…ELW · Traditional | Dent4you AG | 11/15/2024SE |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluELW · Traditional | B&E Korea Co., Ltd. | 02/13/2024SE |
| K223892 | DentMix VPS Impression MaterialELW · Traditional | Innovative Product Brands, Inc. | 04/27/2023SE |
| K213175 | No Stress ImpressELW · Traditional | No Stress Impress, LLC | 01/19/2023SE |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…ELW · Traditional | Genoss Co., Ltd. | 12/15/2022SE |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular…ELW · Traditional | Hdi, Inc. | 11/07/2022SE |
More from Hdi, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K020050 | Enamel Bonding SystemKLE · Traditional | 02/14/2002SE |
| K011822 | Pit and Fissure Chemical Curing SealantEBC · Traditional | 08/07/2001SE |
| K011453 | Tooth Shade Resin MaterialEBF · Traditional | 07/23/2001SE |
| K010255 | Cavity VarnishLBH · Traditional | 04/20/2001SE |
| K010240 | Polycarboxylate (Pca) CementEMA · Traditional | 03/27/2001SE |
| K003427 | Zinc Phosphate CementEMA · Traditional | 01/24/2001SE |
Questions and answers
When was Alginate Impression Material cleared by the FDA?
Alginate Impression Material (K003426) received a 510(k) decision of Substantially Equivalent on January 23, 2001, 81 days after the submission was received.
What is the product code of K003426?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.