510(k) clearances

TriActive Dental Implant System

Paragon Implant Mfg., LLC · Dental

K261392Substantially EquivalentAbbreviatedDZE
Open FDA's page for this record
Third party flag
N
City
Calabasas
Advisory committee description
Dental
Address 1
27030 Malibu Hills Rd.
Statement or summary
Summary
Product code
DZE
Zip code
91301
Applicant
Paragon Implant Mfg., LLC
Decision date
2026-09-17
Decision code
SESE
Country code
US
Device name
TriActive Dental Implant System
Advisory committee
DE
Contact
Renee Bennett
K number
K261392
State
CA
Date received
2026-04-29
Review advisory committee
DE
Postal code
91301
Decision description
Substantially Equivalent
Clearance type
Abbreviated
Harmonized identifiers (openFDA)
Device name
Implant, Endosseous, Root-Form
Medical specialty description
Dental
Regulation number
872.3640
Device class
2
Registration number
3011936113, 3001082453, 2023623, 2245590, 3004201263, 3013111692, 2029275, 3006405073, 2032098, 3007518363, 3006592743, 3025517712, 3015775866, 3004049923, 8020776, 9613283, 9611993, 3011587077, 3015160953, 1424785, 3031462380, 3038549074, 2024024, 3008088588, 3014596751, 3011656326, 9680605, 2031884, 8030870, 8010591, 9611992, 2921595, 3005216725, 3024859204, 3008252900, 3009528826, 3011103459, 3009611645, 3011187779, 2183744 +288 more
FEI number
3011936113, 3001082453, 2023623, 3002807692, 2245590, 3004201263, 3013111692, 3006405073, 3007518363, 3006592743, 3025517712, 3015775866, 3003110073, 3004049923, 3002806651, 3011587077, 3003267134, 3015160953, 1000306551, 3031462380, 3038549074, 3000215273, 2024024, 3008088588, 3014596751, 3011656326, 5870, 2921595, 3005216725, 3002807009, 3024859204, 3002806577, 3008252900, 3009528826, 3011103459, 3003054571, 3009611645, 3011187779, 4224, 2183744 +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.