510(k) clearances

TEMP MASTER, PMMA-based dental resin

Taiwan Dental Materials Co., Ltd. · Dental

K243951Substantially EquivalentTraditionalEBG
Open FDA's page for this record
Third party flag
N
City
Taipei
Advisory committee description
Dental
Address 1
11f., # 136, Sec. 3, Zhongxiao E. Rd., Da’An Dist.
Statement or summary
Summary
Product code
EBG
Zip code
106671
Applicant
Taiwan Dental Materials Co., Ltd.
Decision date
2025-02-21
Decision code
SESE
Country code
TW
Device name
TEMP MASTER, PMMA-based dental resin
Advisory committee
DE
Contact
Pey-Fen Tang
K number
K243951
Date received
2024-12-23
Review advisory committee
DE
Postal code
106671
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Crown And Bridge, Temporary, Resin
Medical specialty description
Dental
Regulation number
872.3770
Device class
2
Registration number
3005665377, 3030515618, 3005628474, 3005350578, 3003231822, 8030452, 1410097, 1413475, 3023346365, 2437780, 3026312357, 3011824442, 1036212, 1937100, 3009409473, 3017374693, 8010711, 3032312561, 2027375, 3011944170, 2280629, 3011814610, 3008912871, 1221541, 2023129, 3002808149, 1450653, 3010664129, 2433919, 3011511773, 3014888923, 3024185724, 3010864832, 3004491043, 3043226252, 3006694515, 3022068322, 3009482106, 2411797, 1417322 +145 more
FEI number
3005665377, 3030515618, 3005628474, 3005350578, 3003231822, 1410097, 1413475, 3023346365, 3026312357, 3011824442, 1036212, 1937100, 3009409473, 3017374693, 3032312561, 2027375, 3011944170, 3002806930, 3002806620, 3011814610, 3008912871, 3003943714, 1221541, 3003667632, 2023129, 3002808149, 1450653, 3010664129, 2433919, 3011511773, 3014888923, 3024185724, 3003999430, 3004491043, 3043226252, 3006694515, 3022068322, 3009482106, 2411797, 1417322 +145 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.