Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007353764

FEI Number

3007353764

Entity Name

SEILGLOBAL CO., LTD

City/State/Country

Busan Gyeongnam, KR

Establishment Address

191, Gaejwa-ro, Geumjeong-gu, Busan Gyeongnam 609-845, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Seilglobal CO., Ltd (Owner Number: 10045865)

Owner / Operator Contact Address

191, Gaejwa-ro,, Geumjeong-gu, Busan, KR-NOTA 46259, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ZirADD Disposable Impression Tray JB Tray, JBUT, JBLT, JBUTLT, JBUTR, JBLTR DentiAnn Smart Sil Autoclavable Irrigation Tube Mirror system auto mix tip ADD POP BOW Primary Crown Dual Syringe Flow Syringe Composite Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2025-01-01
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2014-01-07
ELW	Material, Impression	Dental	Class 2	872.3660	2015-03-04
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2024-04-12
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2014-01-07
JEW	Tip, Rubber, Oral Hygiene	Dental	Class 1	872.6650	2014-01-07
KCR	Facebow	Dental	Class 1	872.3220	2021-02-06
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2021-02-06
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2025-07-03

Official Correspondent

Ethan Ha

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

Seilglobal 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
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

Similar Registrations

Registration Number	Establishment Name	Location
3011545201	KI. WORKS VIETNAM CO., LTD	Mongkok, Kln., Hong Kong, HK
2515379	DENTSPLY LLC	MILFORD, DE, US
1719513	MEDTECH PRODUCTS, INC.	Tarrytown, NY, US
3040335058	INDIVATION EXPORTS PRIVATE LIMITED	Gurugram Haryana, IN
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007353764. Last updated year: 2026. Please use registration number 3007353764 when referencing this establishment in official correspondence.