510(k) clearances

Synthetic Bone Graft Particulate

Shenzhen Dazhou Medical Technology Co., Ltd. · Dental

K241186Substantially EquivalentTraditionalLYC
Open FDA's page for this record
Third party flag
N
City
Shenzhen
Advisory committee description
Dental
Address 1
St B605, Bldg. #1, Yesun Intelligent Community Ii, 1301-76
Address 2
Guanguang Rd., Longhua District
Statement or summary
Summary
Product code
LYC
Zip code
518110
Applicant
Shenzhen Dazhou Medical Technology Co., Ltd.
Decision date
2025-02-21
Decision code
SESE
Country code
CN
Device name
Synthetic Bone Graft Particulate
Advisory committee
DE
Contact
Jingzhou Yang
K number
K241186
Date received
2024-04-29
Review advisory committee
DE
Postal code
518110
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Bone Grafting Material, Synthetic
Medical specialty description
Dental
Regulation number
872.3930
Device class
2
Registration number
3018094310, 1410097, 8043792, 3011824442, 1650372, 1221541, 2530154, 3015219237, 3004203816, 3027448274, 3008114965, 2648988, 3008328709, 3008812560, 3006017180, 1066741, 3002807310, 2249852, 9613348, 2081055, 3016050940, 3004431266, 3011050570, 9612827, 3010160527, 3007663067, 3010162973, 2024024, 2650143, 1058584, 3003300673, 3007225376, 3006540014, 3004450973, 3002807315, 2024311, 9612300, 1319639, 3003771570, 1000194445 +55 more
FEI number
1000477302, 3018094310, 1410097, 3011824442, 3002808269, 1221541, 3015219237, 3004203816, 2431866, 3027448274, 3008114965, 3008328709, 3008812560, 3006017180, 3002253367, 3002807310, 2648209, 2081055, 1000138054, 3002807040, 3016050940, 3004431266, 3011050570, 1000307073, 1000305589, 3007663067, 2024024, 3003300673, 3003854593, 3007225376, 3000215273, 3006540014, 3004450973, 3005907356, 3002807315, 1000306139, 3003058448, 2024311, 1000477999, 3002807305 +55 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.