Hyunjae Dental Impression Materials

Q: What is the product code of K962680?

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

FDA 510(k) K962680 · Hyunjae Corp.

Substantially Equivalent

510(k) numberK962680

Submission

Device name: Hyunjae Dental Impression Materials
Applicant: Hyunjae Corp.
New Milford, CT, US
Received: July 10, 1996
Decision date: September 30, 1996
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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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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
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More from Hdi, Inc.

510(k)	Device	Decision
K973927	Hyunjae Corporation - Nusil Earmold Impression MaterialESD · Traditional	12/11/1997SE

Questions and answers

When was Hyunjae Dental Impression Materials cleared by the FDA?

Hyunjae Dental Impression Materials (K962680) received a 510(k) decision of Substantially Equivalent on September 30, 1996, 82 days after the submission was received.

What is the product code of K962680?

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