510(k) clearances

Any-Zircos

Mediclus Co., Ltd. · Dental

K262074Substantially EquivalentTraditionalEIH
Open FDA's page for this record
Third party flag
N
City
Cheongju-Si
Advisory committee description
Dental
Address 1
# 1210, 134, Gongdan-Ro, Heungdeok-Gu
Statement or summary
Summary
Product code
EIH
Zip code
28576
Applicant
Mediclus Co., Ltd.
Decision date
2026-08-21
Decision code
SESE
Country code
KR
Device name
Any-Zircos
Advisory committee
DE
Contact
Ku Da Hyeon
K number
K262074
Date received
2026-06-22
Review advisory committee
DE
Postal code
28576
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
3008190898, 1064583, 3014683120, 3017674095, 2523320, 3039433962, 3015332784, 3010905160, 3031886796, 3038715999, 3014945384, 3007160911, 3009907932, 3010564008, 3035983708, 1420089, 1222802, 9613953, 3009409473, 3003775534, 3009300369, 3009740550, 9613348, 3009482106, 9681199, 3013551048, 3015978392, 3044771104, 3006110126, 1000426619, 9681531, 3007518500, 9614977, 3005942449, 3040605150, 1420052, 3014980456, 3031841433, 3030536692, 3015108415 +122 more
FEI number
3008190898, 3014683120, 3017674095, 2523320, 3039433962, 3015332784, 3010905160, 3031886796, 4838, 3038715999, 3014945384, 3007160911, 3009907932, 3010564008, 3035983708, 1420089, 3002808289, 3009409473, 3003775534, 3009300369, 3009740550, 1000269600, 3009482106, 3013551048, 3015978392, 3002807052, 3002806930, 3044771104, 3006110126, 3002088145, 1000426619, 3000206706, 3007518500, 3005942449, 3040605150, 3004975279, 3002806651, 1420052, 3008501562, 3014980456 +122 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

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.