Infimed Dental System
FDA 510(k) K962422 · Infimed, Inc.
510(k) numberK962422
Submission
- Device name
- Infimed Dental System
- Applicant
- Infimed, Inc.
Liverpool, NY, US - Received
- June 24, 1996
- Decision date
- September 11, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K253864 | NOMAD Pro 3EHD · Traditional | Dental Imaging Technologies Corporation | 03/20/2026SE |
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| K254018 | Portable Dental X-ray Device (GT-1)EHD · Traditional | Guilin Refine Medical Instrument Co., Ltd. | 02/19/2026SE |
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| K242185 | Rextar ProEHD · Traditional | Raypia Co., Ltd. | 12/04/2024SE |
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| 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 Infimed Dental System cleared by the FDA?
Infimed Dental System (K962422) received a 510(k) decision of Substantially Equivalent on September 11, 1997, 444 days after the submission was received.
What is the product code of K962422?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.