Alginate Impression Material
FDA 510(k) K760981 · Adp Intl., Inc.
510(k) numberK760981
Submission
- Device name
- Alginate Impression Material
- Applicant
- Adp Intl., Inc.
Mchenry, IL, US - Received
- October 21, 1976
- Decision date
- November 15, 1976
- 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 |
|---|---|---|
| K760988 | Dental Handpieces · Traditional | 11/15/1976SE |
| K760987 | Diamond StonesDZP · Traditional | 11/15/1976SE |
| K760986 | Carbide Dental BursEJL · Traditional | 11/15/1976SE |
| K760985 | Hand InstrumentsEKW · Traditional | 11/15/1976SE |
| K760984 | Orthodontic InstrumentsJEX · Traditional | 11/15/1976SE |
| K760983 | Endodontic InstrumentsEKN · Traditional | 11/15/1976SE |
| K760982 | Dental VarnishLBH · Traditional | 11/15/1976SE |
| K760980 | Dental AlloyEJJ · Traditional | 11/15/1976SE |
| K760979 | Composite MaterialEBF · Traditional | 11/15/1976SE |
| K760978 | Zinc CementEMA · Traditional | 11/15/1976SE |
Questions and answers
When was Alginate Impression Material cleared by the FDA?
Alginate Impression Material (K760981) received a 510(k) decision of Substantially Equivalent on November 15, 1976, 25 days after the submission was received.
What is the product code of K760981?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.