510(k) clearances

Endoform Dental Membrane

Aroa Biosurgery , Ltd. · Dental

K231305Substantially EquivalentTraditionalNPL
Open FDA's page for this record
Third party flag
N
City
Auckland
Advisory committee description
Dental
Address 1
2 Kingsford Smith Pl.
Address 2
Airport Oaks
Statement or summary
Summary
Product code
NPL
Zip code
2022
Applicant
Aroa Biosurgery , Ltd.
Decision date
2024-01-23
Decision code
SESE
Country code
NZ
Device name
Endoform Dental Membrane
Advisory committee
DE
Contact
Tina O'Brien
K number
K231305
Date received
2023-05-05
Review advisory committee
DE
Postal code
2022
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Barrier, Animal Source, Intraoral
Medical specialty description
Dental
Regulation number
872.3930
Device class
2
Registration number
3004431266, 3004884150, 3043657402, 3030833497, 3011649314, 3014206569, 3010155661, 3013037032, 3016823837, 2032542, 3009039068, 2087119, 8043792, 1835959, 3011824442, 3019834892, 3017399129, 3002808022, 3010097171, 3014448321, 3002807112, 3007113424, 3003300673, 3008729892, 3007679154, 1650372, 3009443653, 2530154, 1047843, 3009598981, 3027448274, 3002719998, 1319660, 3002924436, 1000393132, 3013820501, 1313525, 2245304, 3006017180, 3016668451 +17 more
FEI number
3004431266, 3004884150, 3043657402, 3004266672, 3011649314, 3014206569, 3030833497, 1000307073, 3010155661, 3013037032, 3016823837, 3009039068, 3011824442, 3019834892, 1000125147, 3017399129, 3002808022, 3010097171, 3000303710, 3014448321, 1000136478, 3002807112, 3007113424, 3003300673, 3002808269, 3007679154, 3009443653, 3003005156, 1000306051, 3004975279, 1047843, 3009598981, 3027448274, 3002719998, 1317628, 3002924436, 1000393132, 3013820501, 2245304, 3002340648 +17 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.