Air Techniques High Frequency Intra-Oral X-Ray

Q: What is the product code of K111330?

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

FDA 510(k) K111330 · Skanray Technologies

Substantially Equivalent

510(k) numberK111330

Submission

Device name: Air Techniques High Frequency Intra-Oral X-Ray
Applicant: Skanray Technologies
Mysore, IN
Received: May 11, 2011
Decision date: May 27, 2011
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

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

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K252110	Dental X-RAY Unit (AJX200)EHD · Traditional	Guangzhou Ajax Medical Equipment Co., Ltd.	03/12/2026SE
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K251438	Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )EHD · Special	Guilin Woodpecker Medical Instrument Co., Ltd.	09/04/2025SE
K242185	Rextar ProEHD · Traditional	Raypia Co., Ltd.	12/04/2024SE
K242591	XERO-alphaEHD · Traditional	DRTECH Corporation	11/01/2024SE
K241963	WerayEHD · Traditional	Picopack Co., Ltd.	07/30/2024SE
K241305	LifeRay Intraoral Handheld X-ray SystemEHD · Traditional	Lucas Lifecare	07/05/2024SE

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Questions and answers

When was Air Techniques High Frequency Intra-Oral X-Ray cleared by the FDA?

Air Techniques High Frequency Intra-Oral X-Ray (K111330) received a 510(k) decision of Substantially Equivalent on May 27, 2011, 16 days after the submission was received.

What is the product code of K111330?

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