Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015532219

FEI Number

3015532219

Entity Name

SMDsolutions Corp.

City/State/Country

Seoul, KR

Establishment Address

98, Gasan digital 2-ro, Geumcheon-gu, Seoul, Republic of Korea, Seoul 03080, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SMD Solution Co., Ltd. (Owner Number: 10060799)

Owner / Operator Contact Address

Jongno-gu, Daehak-ro 101, Seoul National University Dental Hospital 107-1Ho, Seoul, KR-NOTA 03080, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Comoral Oral Irrigation Unit Comoral H

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2019-06-25

Official Correspondent

Hyun Jeong Kim

US Agent Details

Emily Matorin Business: FDAbasics LLC Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

SMD Solution Co., Ltd.

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
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015532219. Last updated year: 2026. Please use registration number 3015532219 when referencing this establishment in official correspondence.