SONENDO, INC.

FDA Device Registration & Listing · Laguna Hills, CA, US · Registration 3010817521

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010817521
FEI Number
3010817521
Entity Name
SONENDO, INC.
City/State/Country
Laguna Hills, CA, US
Establishment Address
26061 Merit Circle, Suite 101, Laguna Hills, CA 92653, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Sonendo, Inc. (Owner Number: 10046931)
Owner / Operator Contact Address
26061 Merit Circle, Suite 101, Laguna Hills, CA 92653, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Ergo Arm

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2025-11-26
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2018-02-07

Official Correspondent

Sunita Mehta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sonendo, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K864976 Endo Technic Corp. SOLUSET CALCIUM DEMINERALIZING SOLUTION 1987-02-27

Similar Registrations

Registration Number Establishment Name Location
3042158426 INCI DENTAL TIBBI MALZEME SANAYI VE TICARET LIMITED SIRKETI Istanbul, TR
3002692886 MANI, INC. (HEAD OFFICE) UTSUNOMIYA Tochigi, JP
1215305 PULPDENT CORPORATION Watertown, MA, US
3007284437 ORTHO ARCH COMPANY INC Schaumburg, IL, US
2437780 CARGUS INT'L, INC. CONGERS, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010817521. Last updated year: 2026. Please use registration number 3010817521 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.