510(k) clearances

LiteSet Trays

Nobel Biocare AB · General Hospital

K253988Substantially EquivalentTraditionalKCT
Open FDA's page for this record
Third party flag
N
City
Goteborg
Advisory committee description
General Hospital
Address 1
Vastra Hamngatan 1
Statement or summary
Summary
Product code
KCT
Zip code
SE 411 17
Applicant
Nobel Biocare AB
Decision date
2026-09-08
Decision code
SESE
Country code
SE
Device name
LiteSet Trays
Advisory committee
HO
Contact
Bernice Jim
K number
K253988
Date received
2025-12-12
Review advisory committee
HO
Postal code
SE 411 17
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Medical specialty description
General Hospital
Regulation number
880.6850
Device class
2
Registration number
1723170, 3009968482, 1835251, 1221934, 1417592, 3001082453, 3013247477, 1450428, 3008132392, 3008693672, 1314417, 3004491689, 1834331, 3008309062, 2431166, 3004201263, 3013111692, 3010041511, 2081135, 9611274, 1418479, 3013283620, 3010057495, 3015895145, 3006008984, 9613277, 1030489, 3026606306, 3005900820, 3015612252, 3014003062, 3008959420, 3013077751, 1062741, 1416980, 1833920, 3007367732, 3010885402, 3009539885, 3015537048 +255 more
FEI number
3002980729, 3009968482, 3002806315, 1221934, 1417592, 3001082453, 3013247477, 1450428, 3001551180, 3002807692, 3008132392, 3008693672, 1314417, 3004491689, 3008309062, 3004201263, 3003756809, 3010041511, 3013111692, 2081135, 3000302153, 1418479, 3013283620, 3010057495, 3015895145, 3006008984, 3003944071, 3026606306, 3005900820, 3015612252, 3014003062, 3002807169, 3008959420, 3013077751, 1416980, 3007367732, 3010885402, 3009539885, 3015537048, 3043164947 +255 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.