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

Yuseong-gu Daejeon, KR

ARUM DENTISTRY Co., Ltd. appears in FDA device records in Yuseong-gu Daejeon, KR. FDA records list 17 510(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
17
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 17 510(k) clearances for ARUM DENTISTRY Co., Ltd. between 2020 and 2025. The busiest year on record is 2024, with 5. The most recent is 2025, with 4.

Clearances by year, as a table
510(k) clearance decisions for ARUM DENTISTRY Co., Ltd., by decision year
YearClearances
20201
20211
20222
20234
20245
20254
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250280SD TL Implant SystemDZESubstantially Equivalent
K250063ARENA Star, Galaxy StarEIHSubstantially Equivalent
K241703SD Implant SystemDZESubstantially Equivalent
K242753SD TL Implant SystemDZESubstantially Equivalent
K242245Customized AbutmentNHASubstantially Equivalent
K232559C&B NFH HybridEBFSubstantially Equivalent
K240603Ti-Base & Master FixNHASubstantially Equivalent
K234112Customized AbutmentNHASubstantially Equivalent
K240091NB Mini Implant SystemDZESubstantially Equivalent
K232560Angled AbutmentNHASubstantially Equivalent
K230725NB Implant SystemDZESubstantially Equivalent
K223634Customized AbutmentNHASubstantially Equivalent
K223253Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)EIHSubstantially Equivalent
K222131NB 1 SA Implant SystemDZESubstantially Equivalent
K213506NB 1 SA Implant SystemDZESubstantially Equivalent
K210817C&B 5.0 HybridEBGSubstantially Equivalent
K193425Pre-Milled BlankNHASubstantially Equivalent

Registered establishments

FDA registered establishments for ARUM DENTISTRY Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30159783923015978392ARUM DENTISTRY Co., Ltd.23, Gukjegwahak 11-ro, Yuseong-gu Daejeon 34002 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

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