# Orametrix, Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/orametrix-inc>
- Registered in EUDAMED as: OraMetrix (OraMetrix)
- Country: United States (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: US-MF-000018045
- DUNS: 053101262

## Figures

- Devices: 30
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0
- FDA establishments: 1

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 29, EUDAMED 3, FDA 510(k) 1
- Device classes: FDA Class I 21, FDA Class II 9

## Devices

The first 30 of 30, in the order of the canonical page, which lists them all.

- [SureSmile® 2000](https://devicerts.com/devices/suresmile-r-2000-assy500020) · Class II · GUDID · status: Listed
- [SureSmile® ASSY-000110](https://devicerts.com/devices/suresmile-r-assy-000110) · Class I · GUDID · status: Listed
- [Motto ASSY-500017](https://devicerts.com/devices/motto-assy-500017) · Class II · GUDID · status: Listed
- [SureSmile Advanced Software 7.6](https://devicerts.com/devices/suresmile-advanced-software-digi-500159) · Class I · EUDAMED, GUDID · status: Active
- [SureSmile® ASSY-000580](https://devicerts.com/devices/suresmile-r-assy-000580) · Class I · GUDID · status: Listed
- [SureSmile® ASSY-000471](https://devicerts.com/devices/suresmile-r-assy-000471) · Class I · GUDID · status: Listed
- [SureSmile® DIGI-500128](https://devicerts.com/devices/suresmile-r-digi-500128) · Class I · GUDID · status: Listed
- [SureSmile Ortho Software 7.6](https://devicerts.com/devices/suresmile-ortho-software-digi-500153) · Class I · EUDAMED, GUDID · status: Active
- [Motto ASSY-500019](https://devicerts.com/devices/motto-assy-500019) · Class I · GUDID · status: Listed
- [SureSmile® ASSY-000472](https://devicerts.com/devices/suresmile-r-assy-000472) · Class I · GUDID · status: Listed
- [Motto ASSY-500118](https://devicerts.com/devices/motto-assy-500018) · Class II · GUDID · status: Listed
- [SureSmile® ASSY-000116](https://devicerts.com/devices/suresmile-r-assy-000116) · Class I · GUDID · status: Listed
- [SureSmile attachment template 3000](https://devicerts.com/devices/suresmile-attachment-template-assy-500010) · Class II · GUDID · status: Listed
- [SureSmile® ASSY-000469](https://devicerts.com/devices/suresmile-r-assy-000469) · Class I · GUDID · status: Listed
- [SureSmile® ASSY-000112](https://devicerts.com/devices/suresmile-r-assy-000112) · Class I · GUDID · status: Listed
- [sureclear template 2000](https://devicerts.com/devices/sureclear-template-2000) · Class II · GUDID · status: Active
- [SureSmile® ASSY-000117](https://devicerts.com/devices/suresmile-r-assy-000117) · Class I · GUDID · status: Listed
- [SureSmile Aligner Software 7.6](https://devicerts.com/devices/suresmile-aligner-software-7-6) · Class I · EUDAMED, GUDID · status: Active
- [SureSmile® 1000](https://devicerts.com/devices/suresmile-r-assy-500011) · Class II · GUDID · status: Listed
- [SureSmile® ASSY-000108](https://devicerts.com/devices/suresmile-r-assy-000108) · Class I · GUDID · status: Listed
- [SureSmile® ASSY-000470](https://devicerts.com/devices/suresmile-r-assy-000470) · Class I · GUDID · status: Listed
- [sureclear aligner 1000](https://devicerts.com/devices/sureclear-aligner-1000) · Class II · GUDID · status: Active
- [SureSmile® 1000](https://devicerts.com/devices/suresmile-r-assy-500016) · Class II · GUDID · status: Listed
- [SureSmile® ASSY-000115](https://devicerts.com/devices/suresmile-r-assy-000115) · Class I · GUDID · status: Listed
- [SureSmile® ASSY-000473](https://devicerts.com/devices/suresmile-r-assy-000473) · Class I · GUDID · status: Listed
- [SureSmile® ASSY-000109](https://devicerts.com/devices/suresmile-r-assy-000109) · Class I · GUDID · status: Listed
- [SureSmile® 1000](https://devicerts.com/devices/suresmile-r-assy-500015) · Class I · GUDID · status: Listed
- [SureSmile® ASSY-000149](https://devicerts.com/devices/suresmile-r-assy-000149) · Class I · GUDID · status: Listed
- [SureSmile attachment template 2000](https://devicerts.com/devices/suresmile-attachment-template-2000) · Class II · GUDID · status: Withdrawn
- [Suresmile System](https://devicerts.com/devices/suresmile-system-eia) · ref K002620 · Class I · 510(k) · status: Active · decision 2000-11-16

## EU certificates

- G10 061588 0012 · Quality management system · MDR · notified body TÜV SÜD Product Service GmbH · issued 2025-02-27 · expires 2030-05-13 · status: reissued

## Source and citation

- Cite as: Orametrix, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/orametrix-inc (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/orametrix-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/orametrix-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.