510(k) clearances

SD Implant System

Arum Dentistry Co., Ltd. · Dental

K241703Substantially EquivalentTraditionalDZE
Open FDA's page for this record
Third party flag
N
City
Daejeon
Advisory committee description
Dental
Address 1
23 Gukjegwahak 11-Ro, Yuseong-Gu
Statement or summary
Summary
Product code
DZE
Zip code
34002
Applicant
Arum Dentistry Co., Ltd.
Decision date
2025-02-24
Decision code
SESE
Country code
KR
Device name
SD Implant System
Advisory committee
DE
Contact
Choi Won-Yi
K number
K241703
Date received
2024-06-13
Review advisory committee
DE
Postal code
34002
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.