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

Daegu, KR

ONEDAY BIOTECH appears in FDA device records in Daegu, KR. FDA records list 2 510(k) clearances between and , no PMA records and 2 registered establishments. 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
2
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 2 510(k) clearances for Oneday Biotech between 2023 and 2024. The busiest year on record is 2023, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Oneday Biotech, by decision year
YearClearances
20231
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K231753Oneday Implant AbutmentNHASubstantially Equivalent
K222946Oneday Mini Implant SystemDZESubstantially Equivalent

Registered establishments

FDA registered establishments for Oneday Biotech, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30374113063037411306ONEDAY BIOTECH1 W Forest Ave Ste 2d, Englewood, NJ 07631 US2026No device listings on this registration
30175486453017548645Oneday Biotech Co., Ltd.135 C SEONGSEODONGRO DALSEOGU, DAEGU 42721 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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What MDM checks, and what it does not

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