510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Diadent Group International

CHONGJU CITY Chungbuk, KR

DIADENT GROUP INTERNATIONAL appears in FDA device records in CHONGJU CITY Chungbuk, KR. FDA records list 22 510(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
22
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 22 510(k) clearances for Diadent Group International between 2013 and 2026. The busiest year on record is 2020, with 10. The most recent is 2026, with 4.

Clearances by year, as a table
510(k) clearance decisions for Diadent Group International, by decision year
YearClearances
20131
20192
202010
20212
20222
20231
20264
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261166DIA-CEMEMASubstantially Equivalent
K261093DIAFILEBFSubstantially Equivalent
K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)EBFSubstantially Equivalent
K254112Dia-X Sil BiteELWSubstantially Equivalent
K231552Dia-CemEMASubstantially Equivalent
K220804Dia-X Bond UniversalKLESubstantially Equivalent
K213401DIAPLUS UniversalKLESubstantially Equivalent
K210421Diafil & Diafil CapsuleEBFSubstantially Equivalent
K210333DiaPasteKIFSubstantially Equivalent
K200174DIA-ROOT BIO MTAKIFSubstantially Equivalent
K200809D-LUX+EBZSubstantially Equivalent
K200175DIA-ROOT BIO SealerKIFSubstantially Equivalent
K192392DiaPlusKLESubstantially Equivalent
K190091DiapasteKIFSubstantially Equivalent
K192284DiaFil FlowEBFSubstantially Equivalent
K192510DIAFIL & DIAFIL CapsuleEBFSubstantially Equivalent
K192158DiaTempEBGSubstantially Equivalent
K192022DiaTemp FlowEBGSubstantially Equivalent
K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro KitKLESubstantially Equivalent
K182009Dia-ProsealKIFSubstantially Equivalent
K182625Diapex PlusKIFSubstantially Equivalent
K130163D-LUXEBZSubstantially Equivalent

Registered establishments

FDA registered establishments for Diadent Group International, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96161283010138769DIADENT GROUP INTERNATIONAL16, Osongsaengmyeong 4-Ro, Osong-Eup, CHONGJU CITY Chungbuk 28161 KR2026and 13 more, listed in full below

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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What MDM checks, and what it does not

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