Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Implant Direct Sybron Manufacturing, LLC · Predicate Candidate Screening

17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

209 daysmedian FDA review time
306 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC2023-08-161210
K223535SMARTbase Abutment SystemImplant Direct Sybron Manufacturing, LLC2023-06-202091
K222211Implant Direct Dental Implant Systems Portfolio - MR ConditiImplant Direct Sybron Manufacturing, LLC2023-02-021920
K202524Standard Sterilizable TrayImplant Direct Sybron Manufacturing, LLC2021-01-281490
K201553Simply Iconic ImplantsImplant Direct Sybron Manufacturing, LLC2021-01-222260
K200858Mini Sterilizable TrayImplant Direct Sybron Manufacturing, LLC2020-08-061271
K200265Surgical DrillsImplant Direct Sybron Manufacturing, LLC2020-06-301480
K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dentImplant Direct Sybron Manufacturing, LLC2020-06-253150
K192218Custom Legacy and Custom InterActive Titanium AbutmentsImplant Direct Sybron Manufacturing, LLC2020-05-082670
K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC2019-10-101320
K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC2018-08-15850
K162633Custom BarsImplant Direct Sybron Manufacturing, LLC2017-07-243060
K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC2016-08-262630
K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC2015-07-162690
K142519InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC2015-04-152190
K130572INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEMImplant Direct Sybron Manufacturing, LLC2013-12-242950
K131097LEGACY3 6MM LENGTH IMPLANTSImplant Direct Sybron Manufacturing, LLC2013-08-221260

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda