Accuflex/Accumix Vinyl Poly Impression Materials
FDA 510(k) K903292 · Coe Laboratories, Inc.
510(k) numberK903292
Submission
- Device name
- Accuflex/Accumix Vinyl Poly Impression Materials
- Applicant
- Coe Laboratories, Inc.
Alsip, IL, US - Received
- July 24, 1990
- Decision date
- October 19, 1990
- 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 |
|---|---|---|
| K894282 | First Impression TMELW · Traditional | 12/22/1989SE |
| K894281 | First Impression with ChlorhexidineELW · Traditional | 09/26/1989SE |
| K891140 | Occlu-Seal(Tm) Visible Light-Cured Fissure SealantEBC · Traditional | 05/01/1989SE |
| K885010 | Tripton(Tm) Visible Light-Cured Univ. BondingKLE · Traditional | 02/13/1989SE |
| K881422 | Coe Pak Auto Mix, Regular or Hard SetEMA · Traditional | 10/31/1988SE |
| K881091 | Omnisil, Vinyl Polysiloxane Impression MaterialELW · Traditional | 06/28/1988SE |
| K863882 | Opalux Visible Light Cured Anterior CompositeEBF · Traditional | 11/18/1986SE |
| K842877 | Absolute Vinyl Polysiloxane ImpressELW · Traditional | 03/11/1985SE |
| K844325 | Coe-Lite Polymerization UnitEBZ · Traditional | 12/11/1984SE |
| K844326 | Occlusin Light Cured Visible Radiopaque CompositeEBF · Traditional | 12/03/1984SE |
Questions and answers
When was Accuflex/Accumix Vinyl Poly Impression Materials cleared by the FDA?
Accuflex/Accumix Vinyl Poly Impression Materials (K903292) received a 510(k) decision of Substantially Equivalent on October 19, 1990, 87 days after the submission was received.
What is the product code of K903292?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.