Atlas FDA

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

Sci-Pharm, Inc. — Predicate Candidate Screening

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

21 daysmedian FDA review time
40 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K823935MICRO JOIN, CROWN & BRIDGE ADHESIVESci-Pharm, Inc.1983-02-07400
K820092SECURE-ON-TOUCHSci-Pharm, Inc.1982-02-24420
K813090COMPOSITE DENTAL RESTORATIVE MATERIALSci-Pharm, Inc.1981-11-24220
K813091FISSURE SEALER & BONDING AGENTSci-Pharm, Inc.1981-11-24220
K812550BEAUCAVSci-Pharm, Inc.1981-09-25210
K812546BEAUDENTSci-Pharm, Inc.1981-09-25210
K812548COBEAUSci-Pharm, Inc.1981-09-25210
K812549BEAUSEALSci-Pharm, Inc.1981-09-25210
K812545BEAUFILLSci-Pharm, Inc.1981-09-25210
K812547BEAUBONSci-Pharm, Inc.1981-09-23190
K812551BEAUCORSci-Pharm, Inc.1981-09-23190
K810715SECURESci-Pharm, Inc.1981-04-21350
K810959SECURESci-Pharm, Inc.1981-04-21130
K810479SUPPORTSci-Pharm, Inc.1981-03-17220
K810210MAGIC-TOUCHSci-Pharm, Inc.1981-02-10150

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