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Unit, X-Ray, Intraoral
FDA product code EAP · Class 2 · Dental
312
Registered devices
592
Adverse events
6
Recalls
42
510(k) clearances
Devices with this code
RVG 6100 — CARESTREAM HEALTH, INC.Schick33 — SIRONA DENTAL, INC.CDR — SIRONA DENTAL, INC.CDR — SIRONA DENTAL, INC.CDR — SIRONA DENTAL, INC.RVG 6200 — CARESTREAM DENTAL LLCCDR — SIRONA DENTAL, INC.CDR — SIRONA DENTAL, INC.CDR — SIRONA DENTAL, INC.RVG 6200 — CARESTREAM HEALTH, INC.RVG 6200 — CARESTREAM DENTAL LLCRVG 6100 — CARESTREAM DENTAL LLCSCHICK33 — SIRONA DENTAL, INC.SCHICK33 — SIRONA DENTAL, INC.CDR — SIRONA DENTAL, INC.SCHICK33 — SIRONA DENTAL, INC.Schick33 — SIRONA DENTAL, INC.RVG CONNECT — CARESTREAM HEALTH, INC.RVG 6100 — CARESTREAM HEALTH, INC.Schick33 — SIRONA DENTAL, INC.SCHICK33 — SIRONA DENTAL, INC.Schick — Dentsply International Inc.RVG 6100 — CARESTREAM DENTAL LLCCDR — SIRONA DENTAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-09-26 | DeGotzen | It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification |
| 2012-09-18 | Trophy Sas | There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed th |
| 2012-09-18 | Trophy Sas | There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed th |
| 2012-09-18 | Trophy Sas | There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed th |
| 2012-09-18 | Trophy Sas | There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed th |
| 2012-07-03 | Chicago X-Ray Systems, Inc. | The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Also, the user's manual was found to have mi |
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