510(k) clearances

LONGY Implant and LONGY-N Implant

Noris Medical , Ltd. · Dental

K241462Substantially EquivalentTraditionalDZE
Open FDA's page for this record
Third party flag
N
City
Nesher
Advisory committee description
Dental
Address 1
8 Hataasia St.
Statement or summary
Summary
Product code
DZE
Zip code
3688808
Applicant
Noris Medical , Ltd.
Decision date
2025-02-11
Decision code
SESE
Country code
IL
Device name
LONGY Implant and LONGY-N Implant
Advisory committee
DE
Contact
Noa Mor
K number
K241462
Date received
2024-05-23
Review advisory committee
DE
Postal code
3688808
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.