Data / Medical devices / United Kingdom / Carestream Dental Technology Topco Limited
Carestream Dental Technology Topco Limited: FDA-registered device maker in London London, City of, United Kingdom, 12 510(k) clearances and 1 PMA approval
Carestream Dental Technology Topco Limited is registered with the FDA (registration 3014398772) in London London, City of, United Kingdom. It lists 9 device types. The FDA files 12 510(k) clearances and 1 PMA approval under its listings, the newest dated April 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014398772
- Address
- C/O Corporation Service Company (Uk) Limited 5 Churchill Place, 10th Floor, London London, City of, United Kingdom, E14 5HU
- Owner or operator
- Carestream Dental LLC (10056540)
- Roles
- Exporter to the US
- First device listed
- December 20, 2017
- Registered through
- 2026
- Brand names listed
- 7600 Hygienic Sheaths size 0, 7600 Hygienic Sheaths size 1, 7600 Hygienic Sheaths size 2, 7600 Hygienic Sheaths size 3, 7600 Hygienic Sheaths size 4, CG913, CGH99, CGL12 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Medical Image | MYN | 2 | Exporter to the US | accessdata.fda.gov |
| Camera, Surgical And Accessories | KQM | 1 | Exporter to the US | accessdata.fda.gov |
| Film, Radiographic | IWZ | 1 | Exporter to the US | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Exporter to the US | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Exporter to the US | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Exporter to the US | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Exporter to the US | accessdata.fda.gov |
| Unit, X-Ray, Intraoral | EAP | 2 | Exporter to the US | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 21, 2023 | K230811 | Digital Intraoral X-Ray Sensor | MUH | Substantially Equivalent | Iray Imaging Technology (Haining) Limited | accessdata.fda.gov |
| March 13, 2020 | K200183 | CS 9600 | OAS | Substantially Equivalent | Trophy | accessdata.fda.gov |
| May 24, 2018 | K181136 | CS 9600 | OAS | Substantially Equivalent | Trophy | accessdata.fda.gov |
| January 16, 2018 | K173622 | CS Imaging | LLZ | Substantially Equivalent | Trophy | accessdata.fda.gov |
| October 26, 2017 | K173046 | Cocoon Portable Handheld X-Ray System | MUH | Substantially Equivalent | Dexcowin Co., Ltd. | accessdata.fda.gov |
| August 21, 2015 | K151087 | CS 8100SC, CS8100SC Access | MUH | Substantially Equivalent | Trophy | accessdata.fda.gov |
| August 19, 2015 | K151837 | CS 3D Imaging | LLZ | Substantially Equivalent | Trophy | accessdata.fda.gov |
| March 14, 2014 | K133406 | CS 8100 3D | OAS | Substantially Equivalent | Trophy | accessdata.fda.gov |
| June 22, 2012 | K120975 | CS 8100 CS 8100 ACCESS | MUH | Substantially Equivalent | Trophy | accessdata.fda.gov |
| January 25, 2012 | K112251 | SWISSMEDA DENTAL PLANNING SYSTEM | LLZ | Substantially Equivalent | Swissmeda AG | accessdata.fda.gov |
| March 3, 2006 | K060292 | KODAK MODELS 2100 AND 2200 | EHD | Substantially Equivalent | Kodak-Trophy | accessdata.fda.gov |
| April 19, 1995 | K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | EAP | Substantially Equivalent | Trophy Radiologie | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 25, 1998 | P980025 | LOGICON CARIES DETECTOR | MYN | 4 | September 5, 2019 | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of X-Ray, Tomography, Computed, Dental
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of Analyzer, Medical Image
- All makers of Film, Radiographic
Updated April 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.