# Implant Direct Sybron Manufacturing, LLC

- Location (FDA's records): Thousand Oaks, CA
- FDA decisions: 17 (2013–2023): 17 510(k) clearances
- Product codes: NHA (6), DZE (6), KCT (3), DZI (2)
- 510(k) review time since 2016: median 201 days, against 187 for FDA's reviews in the same codes and years (6 of 12 faster)
- Predicates its devices cite: 35 (10 its own); citations of its devices by later devices: 19 (10 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Implant Direct, LLC: 11 (https://510kreport.com/company/implant-direct)
- Bicon, Inc.: 4 (https://510kreport.com/company/bicon)
- Straumann USA: 3 (https://510kreport.com/company/straumann-usa)
- Nobel Biocare AB: 2 (https://510kreport.com/company/nobel-biocare)
- Dentsply International, Inc.: 1 (https://510kreport.com/company/dentsply-international)
- Conmed Linvatec: 1 (https://510kreport.com/company/conmed-linvatec)
- Symmetry Medical: 1 (https://510kreport.com/company/symmetry-medical)
- Tuttnauer U.S.A Co, Ltd.: 1 (https://510kreport.com/company/tuttnauer-usa)

## Firms that cite its devices most
- Paragon Implant Mfg., LLC: 3 (https://510kreport.com/company/paragon-implant-mfg)
- Southern Implants (Pty), Ltd.: 2 (https://510kreport.com/company/southern-implants)
- Avinent Implant System S.L.U.: 1 (https://510kreport.com/company/avinent-implant-system-slu)
- Anthogyr: 1 (https://510kreport.com/company/anthogyr)
- Soadco, S.L.: 1 (https://510kreport.com/company/soadco)
- Nobel Biocare AB: 1 (https://510kreport.com/company/nobel-biocare)

## Its most-cited devices
- K142519: InterActive Complete Surgical Tray (2015), cited by 5
- K130572: Interactive/ SWISHPLUS2 Implant System (2013), cited by 3
- K181359: InterActive SMARTBase Abutments (2018), cited by 2
- K192221: Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts (2020), cited by 2
- K202524: Standard Sterilizable Tray (2021), cited by 2
- K143011: 2014 InterActive/SwishActive System (2015), cited by 2

## Recent decisions
- K231087: Guided Surgery Kit (Aug 16, 2023)
- K223535: SMARTbase Abutment System (Jun 20, 2023)
- K222211: Implant Direct Dental Implant Systems Portfolio - MR Conditional (Feb 2, 2023)
- K202524: Standard Sterilizable Tray (Jan 28, 2021)
- K201553: Simply Iconic Implants (Jan 22, 2021)
- K200858: Mini Sterilizable Tray (Aug 6, 2020)
- K200265: Surgical Drills (Jun 30, 2020)
- K192221: Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts (Jun 25, 2020)

Source page: https://510kreport.com/company/implant-direct-sybron-manufacturing