Eagle S/Saevo Slim/D700 Slim

FDA 510(k) K230732 · Alliage S/A Industrias Medica Odontológico.

Substantially Equivalent

510(k) numberK230732

Submission

Device name
Eagle S/Saevo Slim/D700 Slim
Applicant
Alliage S/A Industrias Medica Odontológico.
Recreio Anhanguera, BR
Received
March 16, 2023
Decision date
April 11, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
MUH – System, X-Ray, Extraoral Source, Digital
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

Other 510(k)s with product code MUH

510(k)DeviceApplicantDecision
K251793SOTA Cloud Smart Sensor (1.5)MUH · Traditional Sota Cloud Corp.03/03/2026SE
K252570EzSensor HD, EzSensor UHDMUH · Special Qpix Solutions, Inc.11/10/2025SE
K250687Cocoon Solo (DX-7020s)MUH · Traditional Dexcowin Global, Inc.10/24/2025SE
K251206Digital X-Ray DentiMax Pro Imaging SystemMUH · Traditional Dentimax, Inc.09/24/2025SE
K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan…MUH · Traditional VATECH Co., Ltd.10/25/2024SE
K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)MUH · Special Qpix Solutions, Inc.10/11/2024SE
K241649DUO1 and DUO2MUH · Traditional Zinnovi, Inc.07/05/2024SE
K232325RAYSCAN a-ExpertMUH · Traditional Ray Co., Ltd.04/18/2024SE
K231660Digital image scanner of dentalMUH · Traditional Jiangsu Dynamic Medical Technology Co., Ltd.12/20/2023SE
K233053DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2…MUH · Traditional Dental Imaging Technologies Corporation11/21/2023SE

Questions and answers

When was Eagle S/Saevo Slim/D700 Slim cleared by the FDA?

Eagle S/Saevo Slim/D700 Slim (K230732) received a 510(k) decision of Substantially Equivalent on April 11, 2023, 26 days after the submission was received.

What is the product code of K230732?

The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.