Home › Device types › EHD
Unit, X-Ray, Extraoral With Timer
FDA product code EHD · Class 2 · Dental
1,003
Registered devices
521
Adverse events
18
Recalls
190
510(k) clearances
Devices with this code
XIOS AE — SIRONA DENTAL, INC.Midmark — MIDMARK CORPORATIONMidmark PREVA 2.0 IntraOral Dental X-ray System — MIDMARK CORPORATIONMidmark PREVA 2.0 IntraOral Dental X-ray System — MIDMARK CORPORATIONMidmark PREVA IntraOral Dental X-ray System — MIDMARK CORPORATIONDURAY — Beyes Dental Canada IncMidmark PREVA 2.0 IntraOral Dental X-ray System — MIDMARK CORPORATIONSchick AE — SIRONA DENTAL, INC.BELRAY II — TAKARA BELMONT CORP.XpectVision — Shenzhen Xpectvision Technology Co.,Ltd.Midmark PREVA IntraOral Dental X-ray System — MIDMARK CORPORATIONMidmark VETPRO IntraOral Dental X-ray System — MIDMARK CORPORATIONSchick AE — SIRONA DENTAL, INC.ORTHOPHOS XG — SIRONA Dental Systems GmbHHYBRID S70 — DigiMed Co., Ltd.ORTHOPHOS XG — SIRONA Dental Systems GmbHCDR ELITE — SIRONA DENTAL, INC.X-MIND unity — DE GÖTZEN SRLMidmark — MIDMARK CORPORATIONPREVA, 76" REACH, UK — MIDMARK CORPORATIONMidmark — MIDMARK CORPORATIONSIZE B COLLIMAT. FOR I/O XRAY UNITS — CARESTREAM HEALTH, INC.NOMAD Pro 2™ — ARIBEX, INC.Midmark PREVA 2.0 IntraOral Dental X-ray System — MIDMARK CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-19 | DIGIMED CO., LTD | Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm. |
| 2017-07-14 | Panoramic Rental Corp. | The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule. |
| 2016-08-19 | Panoramic Rental Corp. | Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffecti |
| 2016-07-18 | Aribex Inc | Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Inves |
| 2016-07-18 | Aribex Inc | Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Inves |
| 2015-06-04 | Panoramic Rental Corp. | Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury. |
| 2014-08-12 | Gendex Corp | Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated ar |
| 2014-01-24 | Carestream Health Inc. | Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. |
| 2014-01-24 | Carestream Health Inc. | Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. |
| 2014-01-14 | Instrumentarium Dental, PaloDEx Group Oy | Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013 with a potential flaw in the mounting hardware. A number of wa |
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