Elastic Impression Material

Q: What is the product code of K133071?

The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.

FDA 510(k) K133071 · Rizhao Huge Dental Industry Co., Ltd.

Substantially Equivalent

510(k) numberK133071

Submission

Device name: Elastic Impression Material
Applicant: Rizhao Huge Dental Industry Co., Ltd.
Dover, DE, US
Received: September 30, 2013
Decision date: May 28, 2014
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: ELW – Material, Impression
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3660
Specialty: Dental

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K253501	Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set -…ELW · Traditional	Vigodent Indústria E Comercio Ltda	10/31/2025SE
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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.

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Questions and answers

When was Elastic Impression Material cleared by the FDA?

Elastic Impression Material (K133071) received a 510(k) decision of Substantially Equivalent on May 28, 2014, 240 days after the submission was received.

What is the product code of K133071?

The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.