510(k) K032355
- Device
- ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW
- Applicant
- Dentsply Gendex
- 510(k) number
- K032355
- Product code
- EHD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-25
- Date received
- 2003-07-30
- Regulation
- 872.1800
- Classification name
- Unit, X-Ray, Extraoral With Timer
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- JOHN R MILLER
- Address
- 901 W. Oakton St. Des Plaines IL US 60018 60018
FDA Registration Numbers#
- 8043962
- 3013099020
- 3003528079
- 3022107311
- 1226003
- 3015153900
- 9611445
- 3004884150
- 3012187973
- 3014209556
- 8030876
- 2024980
- 2024949
- 3015502499
- 3015376465
- 3023546785
- 3005843418
- 3009608361
- 1423662
- 3010972172
- 3023861999
- 3009001657
- 3009134655
- 3008361230
- 1054713
- 3005383085
- 3007933232
- 3005172103
- 1419489
- 3005581016
- 3021551875
- 3013779985
- 3013511605
- 3025308469
- 2424472
- 3002819275
- 3029916103
- 3012649815
- 9615832
- 3008770655
- 8044167
- 1526534
- 1523530
- 9615782
- 3010446656
- 3008252267
- 3014980469
- 3011491794
- 3031886796
- 3004706313
- 3014398772
- 3016075921
- 3003934980
- 3002994636
- 3006610845
- 3016875543
- 8020825
- 9614977
- 3005246977
- 3006540014
Source Documents#
Other 510(k) Records For Product Code EHD#
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| K233914 | XVbeam2000 | Shenzhen Xpectvision Technology Co., Ltd. | 2024-02-08 |
| K233395 | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | Alliage S/A Industrias Médico Odontológica | 2024-01-03 |
| K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | De Götzen S.R.L. | 2023-12-28 |
| K232085 | DVAS (DVAS-M, DVAS-W) | Genoray Co., Ltd. | 2023-12-08 |