510(k) clearances

FAgamin®

Tedequim Srl · Dental

K240059Substantially EquivalentTraditionalPHR
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Third party flag
N
City
Córdoba
Advisory committee description
Dental
Address 1
Bv. Los Polacos 6136.
Statement or summary
Summary
Product code
PHR
Zip code
X5147GGP
Applicant
Tedequim Srl
Decision date
2024-05-16
Decision code
SESE
Country code
AR
Device name
FAgamin®
Advisory committee
DE
Contact
Leonor Pasteris
K number
K240059
Date received
2024-01-08
Review advisory committee
DE
Postal code
X5147GGP
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Diammine Silver Fluoride Dental Hypersensitivity Varnish
Medical specialty description
Dental
Regulation number
872.3260
Device class
2
Registration number
3014615644, 1941138, 3009603151, 3007113445, 3006444232, 1281412, 3027618252, 3020703838, 3003130442, 3004140838
FEI number
3014615644, 1941138, 3009603151, 3007113445, 3006444232, 1281412, 3027618252, 3020703838, 3003130442, 3004140838
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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.