510(k) clearances

Paltop Short Implants

Paltop Advanced Dental Solutions, Ltd. · Dental

K232740Substantially EquivalentTraditionalDZE
Open FDA's page for this record
Third party flag
N
City
Caesarea
Advisory committee description
Dental
Address 1
Hashita 5, Industrial Park
Statement or summary
Summary
Product code
DZE
Zip code
3088900
Applicant
Paltop Advanced Dental Solutions, Ltd.
Decision date
2024-05-22
Decision code
SESE
Country code
IL
Device name
Paltop Short Implants
Advisory committee
DE
Contact
Nancy DeAngelo
K number
K232740
Date received
2023-09-07
Review advisory committee
DE
Postal code
3088900
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.