Hydrocolloid Compatible Cream Alginate
FDA 510(k) K802882 · Buffalo Dental Mfg. Co., Inc.
510(k) numberK802882
Submission
- Device name
- Hydrocolloid Compatible Cream Alginate
- Applicant
- Buffalo Dental Mfg. Co., Inc.
Walker, MI, US - Received
- November 17, 1980
- Decision date
- January 28, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code ELW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K955573 | Optiblast Intraoral SandblasterKOJ · Traditional | 05/03/1996SE |
| K945220 | Amalgam CarrierEKI · Traditional | 01/11/1995SE |
| K941954 | Non-Fogging Dental MirrorEKJ · Traditional | 07/08/1994SE |
| K841491 | Conventional Plastic Dental TraysEHY · Traditional | 07/13/1984SE |
| K841490 | Polysulfide Custom Tray MaterialELW · Traditional | 06/27/1984SE |
| K841323 | Fuzzy TrayEHY · Traditional | 06/27/1984SE |
| K820489 | Ultrafine Tray AdhesiveELW · Traditional | 03/19/1982SE |
| K820216 | Ultra-WetELW · Traditional | 02/24/1982SE |
| K802990 | Alginate/Silicone Crown & Bridge MaterELW · Traditional | 02/02/1981SE |
| K802662 | Polycarbonate Temporary CementEMA · Traditional | 12/16/1980SE |
Questions and answers
When was Hydrocolloid Compatible Cream Alginate cleared by the FDA?
Hydrocolloid Compatible Cream Alginate (K802882) received a 510(k) decision of Substantially Equivalent on January 28, 1981, 72 days after the submission was received.
What is the product code of K802882?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.