510(k) clearances

Dentis s-Clean SQ-SL Fixture

Dentis Co., Ltd. · Dental

K240511Substantially EquivalentTraditionalDZE
Open FDA's page for this record
Third party flag
N
City
Dalseo-Gu
Advisory committee description
Dental
Address 1
99, Seongseoseo-Ro, Dalseo-Gu
Statement or summary
Summary
Product code
DZE
Zip code
42718
Applicant
Dentis Co., Ltd.
Decision date
2024-05-20
Decision code
SESE
Country code
KR
Device name
Dentis s-Clean SQ-SL Fixture
Advisory committee
DE
Contact
Gyu Ri Kim
K number
K240511
Date received
2024-02-22
Review advisory committee
DE
Postal code
42718
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Implant, Endosseous, Root-Form
Medical specialty description
Dental
Regulation number
872.3640
Device class
2
Registration number
1226544, 3023265483, 9613866, 3007156625, 3011587630, 1038806, 1424785, 3012635238, 3001561923, 9613283, 3005031178, 3007283751, 3011808221, 3023535580, 3012187973, 3036779616, 3004417597, 8031058, 3030690317, 3009756327, 3007597023, 1036836, 3008088588, 3006034256, 3007135442, 3009727738, 3018077122, 3005554774, 3017840051, 3003402534, 2133778, 2530808, 3005503242, 3011649314, 3010303805, 3009514134, 3003394627, 8044131, 3002807050, 3011461101 +288 more
FEI number
3023265483, 3011587630, 1038806, 3006944200, 3012635238, 3001561923, 3005031178, 3002876349, 3007283751, 3002821504, 3011808221, 3023535580, 3012187973, 3036779616, 3004417597, 3030690317, 3007597023, 1036836, 3008088588, 3006034256, 3007135442, 3009727738, 3018077122, 3005554774, 3017840051, 3003402534, 3005503242, 1000272060, 3011649314, 3010303805, 3009514134, 3003394627, 3003024548, 3002807050, 1000522098, 3011461101, 3016447764, 3010363503, 3014329459, 1000114355 +288 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.