N1

FDA 510(k) K232012 · Osstem Implant Co., Ltd.

Substantially Equivalent

510(k) numberK232012

Submission

Device name
N1
Applicant
Osstem Implant Co., Ltd.
Siheung-Si, KR
Received
July 6, 2023
Decision date
November 28, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EHD – Unit, X-Ray, Extraoral With Timer
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

Other 510(k)s with product code EHD

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K260367Portable Dental X-ray System Model PDX novaEHD · Traditional PDX Co., Ltd.05/27/2026SE
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K252110Dental X-RAY Unit (AJX200)EHD · Traditional Guangzhou Ajax Medical Equipment Co., Ltd.03/12/2026SE
K254018Portable Dental X-ray Device (GT-1)EHD · Traditional Guilin Refine Medical Instrument Co., Ltd.02/19/2026SE
K252909Diagnostic X-Ray Equipment Model POCT22EHD · Traditional Ningbo Runyes Medical Instrument Co., Ltd.02/03/2026SE
K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )EHD · Special Guilin Woodpecker Medical Instrument Co., Ltd.09/04/2025SE
K242185Rextar ProEHD · Traditional Raypia Co., Ltd.12/04/2024SE
K242591XERO-alphaEHD · Traditional DRTECH Corporation11/01/2024SE
K241963WerayEHD · Traditional Picopack Co., Ltd.07/30/2024SE
K241305LifeRay Intraoral Handheld X-ray SystemEHD · Traditional Lucas Lifecare07/05/2024SE

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K233194TS Abutment SystemNHA · Traditional 02/20/2024SE
K232220SS Abutment SystemNHA · Traditional 12/05/2023SE
K222778Osstem Implant SystemDZE · Traditional 09/23/2023SE
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K212303T2OAS · Traditional 09/21/2021SE
K210097Estar-ZEIH · Traditional 07/02/2021SE

Questions and answers

When was N1 cleared by the FDA?

N1 (K232012) received a 510(k) decision of Substantially Equivalent on November 28, 2023, 145 days after the submission was received.

What is the product code of K232012?

The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.