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

SOADCO, S.L. · Predicate Candidate Screening

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

165 daysmedian FDA review time
317 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243128Klockner KitsSOADCO, S.L.2024-12-18790
K230103Klockner AbutmentsSOADCO, S.L.2023-04-241010
K173642KLOCKNER SURGICAL BOXSOADCO, S.L.2018-10-023120
K170022Klockner Vega TiBase for CERECSOADCO, S.L.2017-11-163170
K153098KLOCKNER VEGA DENTAL IMPLANT SYSTEMSOADCO, S.L.2016-04-081650
K151194KLOCKNER DENTAL IMPLANT ABUTMENTS (II)SOADCO, S.L.2016-01-292700
K122988KLOCKNER DENTAL IMPLANT ABUTMENTSSOADCO, S.L.2013-07-192960
K082200KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CSOADCO, S.L.2008-11-251130
K080224KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL SOADCO, S.L.2008-07-031560
K052654KLOCKNER DENTAL IMPLANT, MODEL S3MSOADCO, S.L.2006-01-301260
K010132KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4SOADCO, S.L.2002-06-045040

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