Atlas FDA

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

Biodenta Swiss AG · Predicate Candidate Screening

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

157 daysmedian FDA review time
200 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG2015-12-012000
K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG2015-07-021460
K133884BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND LBiodenta Swiss AG2014-06-131750
K123491BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENTBiodenta Swiss AG2013-05-301980
K122559BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTSBiodenta Swiss AG2013-05-032540
K123512BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MMBiodenta Swiss AG2013-03-281350
K123415BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPEREDBiodenta Swiss AG2013-03-191340
K111003BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVELBiodenta Swiss AG2011-09-151570
K110778BIODENTA CUSTOMIZED ABUTMENTBiodenta Swiss AG2011-07-291300
K093630BIODENTA DENTAL IMPLANT SYSTEMBiodenta Swiss AG2010-06-031920
K100150CERAMICS2IN1Biodenta Swiss AG2010-05-251260

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