510(k) clearances

Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)

Hunan Ceramaster Material Technology Co., Ltd. · Dental

K240772Substantially EquivalentTraditionalEIH
Open FDA's page for this record
Third party flag
N
City
Changsha
Advisory committee description
Dental
Address 1
103, Bldg. B4, Dreamworks, #1 Lantian N. Rd.,
Address 2
Xingsha Industrial Base
Statement or summary
Summary
Product code
EIH
Zip code
410137
Applicant
Hunan Ceramaster Material Technology Co., Ltd.
Decision date
2024-05-20
Decision code
SESE
Country code
CN
Device name
Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)
Advisory committee
DE
Contact
Bin Wang
K number
K240772
Date received
2024-03-21
Review advisory committee
DE
Postal code
410137
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Powder, Porcelain
Medical specialty description
Dental
Regulation number
872.6660
Device class
2
Registration number
3030515618, 3020611371, 3018252381, 3004362235, 1410097, 3030464310, 3034244245, 3011824442, 3014945384, 3009409473, 3003449480, 8010711, 3006110126, 3008912871, 2023129, 3017619362, 3002808149, 2433919, 2082832, 3024792419, 3024185724, 3004491043, 3022068322, 3009482106, 2647456, 3008754429, 1219645, 3034605324, 9613348, 3004905070, 2244842, 3031841433, 3031595584, 3027341558, 3004966444, 9612352, 3007738736, 3044771104, 3007160911, 3012187973 +124 more
FEI number
3030515618, 3020611371, 3018252381, 3004362235, 1410097, 3030464310, 3034244245, 3011824442, 3014945384, 3009409473, 3003449480, 3006110126, 3002806930, 3008912871, 2023129, 3017619362, 3002808149, 3009523116, 2433919, 2082832, 3024792419, 3024185724, 3003999430, 3004491043, 3022068322, 3009482106, 2647456, 3008501562, 3008754429, 1219645, 3034605324, 3004905070, 3000206706, 2244842, 3031841433, 3031595584, 3027341558, 3004966444, 3007738736, 3044771104 +124 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.