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

Changsha Hunan, CN

HUNAN VSMILE BIOTECHNOLOGY CO.,LTD appears in FDA device records in Changsha Hunan, CN. FDA records list 2 510(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
2
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Hunan Vsmile Biotechnology Co.,Ltd between 2022 and 2024. The busiest year on record is 2022, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Hunan Vsmile Biotechnology Co.,Ltd, by decision year
YearClearances
20221
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242407Dental Glass Ceramics Blocks (HT, LT, MT)EIHSubstantially Equivalent
K221242Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankEIHSubstantially Equivalent

Registered establishments

FDA registered establishments for Hunan Vsmile Biotechnology Co.,Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30220683223022068322HUNAN VSMILE BIOTECHNOLOGY CO.,LTDBuilding A4 No. 2450, Yuelu West Avenue,Changsha Hi-tech Development District, Changsha Hunan 410000 CN2026

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