Atlas FDA

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

Blue Sky Bio — Predicate Candidate Screening

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

90 daysmedian FDA review time
259 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky Bio2018-11-09730
K163251Life Essence Universal Porcelain SystemBlue Sky Bio2017-08-042590
K021833MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEMBlue Sky Bio2002-06-1060
K010882BLUE SKY BIO DENTAL IMPLANT SYSTEMBlue Sky Bio2001-09-281890
K000633SYNTHETIC GLASS BONE GRAFT MATERIALBlue Sky Bio2000-05-25900

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