510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Ewoosoft Co., Ltd

Hwaseong-si Gyeonggi, KR

Ewoosoft Co., Ltd appears in FDA device records in Hwaseong-si Gyeonggi, KR. FDA records list 31 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
31
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 31 510(k) clearances for Ewoosoft Co., Ltd between 2013 and 2025. The busiest year on record is 2020, with 5. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Ewoosoft Co., Ltd, by decision year
YearClearances
20133
20151
20164
20173
20181
20192
20205
20214
20223
20233
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250005Clever OneQIHSubstantially Equivalent
K241114EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)LLZSubstantially Equivalent
K231757Ez3D-i /E3QIHSubstantially Equivalent
K230468EzDent WebLLZSubstantially Equivalent
K223820EzDent-i / E2 / Prora View/ Smart M ViewerLLZSubstantially Equivalent
K222069Ez3D-i/E3LLZSubstantially Equivalent
K222145EzDent-i / E2 / Prora View/ Smart M ViewerLLZSubstantially Equivalent
K220003EzOrtho v1.3LLZSubstantially Equivalent
K211795EzDent-i/ E2/ Prora View/ Smart M ViewerLLZSubstantially Equivalent
K211700EzDent WebLLZSubstantially Equivalent
K211793EzOrthoLLZSubstantially Equivalent
K211791Ez3D-i/E3LLZSubstantially Equivalent
K202948EzOrthoLLZSubstantially Equivalent
K202116EzDent-i/ E2/ Prora View/ Smart M ViewerLLZSubstantially Equivalent
K192888EzOrthoLLZSubstantially Equivalent
K200178Ez3D-i /E3LLZSubstantially Equivalent
K192098EzMobileLLZSubstantially Equivalent
K190791Ez3D-i/E3LLZSubstantially Equivalent
K190087EzDent-i / E2 / Prora ViewLLZSubstantially Equivalent
K173863Ez3D-i /E3LLZSubstantially Equivalent
K173094OrthoVisionLLZSubstantially Equivalent
K172364EzDent-i / E2 / Prora ViewLLZSubstantially Equivalent
K163533EzDent-i; E2; ProraViewLLZSubstantially Equivalent
K163539Ez3D-i / E3LLZSubstantially Equivalent
K161246Ez3D-i / E3LLZSubstantially Equivalent
K161117EzDent-i / E2 / Prora ViewLLZSubstantially Equivalent
K152746Ez3D PlusLLZSubstantially Equivalent
K150761Ez3D-i/E3LLZSubstantially Equivalent
K131616EZ3D-I, E3LLZSubstantially Equivalent
K131594EZDENTI-I; E2; PRORA VIEWLLZSubstantially Equivalent
K131570ORTHOVISIONLLZSubstantially Equivalent

Registered establishments

FDA registered establishments for Ewoosoft Co., Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30111890583011189058Ewoosoft Co., Ltd801-ho, Vatechnetworks Bldg., Hwaseong-si Gyeonggi 18449 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain