Orametrix, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000018045
Orametrix, Inc. is a medical device manufacturer based in the United States, with 30 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I and II) as of 15 Nov 2026.
- Devices
- 30
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 29
- EUDAMED 3
- FDA 510(k) 1
- Device classes
- FDA Class I 21
- FDA Class II 9
- Identifiers
- EUDAMED SRN US-MF-000018045
- DUNS 053101262
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
What Orametrix, Inc. makes
Orametrix produces orthodontic archwires, progressive aligners, and retainers designed for dental alignment treatment. Their portfolio also includes CAD/CAM software for digital treatment planning and appliance positioning trays to assist in orthodontic procedures. Examples include aligner systems like Motto and software solutions such as SureSmile Ortho Software, which integrates with digital scanning and treatment design workflows.
The company’s devices are regulated under FDA classifications, including Class I and Class II, with authorisations granted through 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. Products are listed in the FDA’s regulatory databases, ensuring compliance with US medical device requirements. The company operates from the United States.
Catalogue
Search and filter all 30 devicesCompany details
- EUDAMED SRN
- US-MF-000018045
- DUNS number
- 053101262
- EUDAMED status
- Active
- EUDAMED registered name
- OraMetrix
- EUDAMED abbreviated name
- OraMetrix
- Registered address
- 1125 E Campbell Rd, 75081, Richardson, Texas, United States
- Phone
- +1(844)848-0137
- PRRC contact
- Khyati Dave
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 13 May 2030
TÜV SÜD Product Service GmbH 0123 1 certificate
- G10 061588 0012 Active
Quality management system EU MDR
- Issued
- 27 Feb 2025
- Expires
- 13 May 2030
- Valid from
- 14 May 2025
FDA establishments
- OraMetrix GmbH Berlin Brandenburg · DE FEI 3003136642
Frequently asked questions
How many devices does ORAMETRIX, INC. have in the registry?
The registry currently lists 30 devices for ORAMETRIX, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ORAMETRIX, INC.'s devices?
Among its 30 most recently registered devices, ORAMETRIX, INC. has devices listed in EUDAMED (3 devices), FDA 510(k) (1 device) and FDA GUDID (29 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ORAMETRIX, INC.'s devices fall under?
Among its 30 most recently registered devices, the classes recorded for ORAMETRIX, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for ORAMETRIX, INC.?
EUDAMED lists 1 certificate for ORAMETRIX, INC. (quality management system) under MDR. The most recent was issued on 27 Feb 2025.
What are the newest devices from ORAMETRIX, INC. in the registry?
The most recently registered devices listed for ORAMETRIX, INC. include SureSmile® 2000, SureSmile® ASSY-000110, Motto ASSY-500017 and SureSmile Advanced Software 7.6.
Which FDA establishments are linked to ORAMETRIX, INC.?
1 FDA establishment is linked to ORAMETRIX, INC. in the registry; they are listed on the company page.