Atlas FDA

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

Solar Dental Co., Inc. — Predicate Candidate Screening

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

45 daysmedian FDA review time
133 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K871980D-23 DENTURE ADHESIVESolar Dental Co., Inc.1987-06-05140
K861846HYDRON ROOT CANAL FILLING & MARK IV STARTER KITSolar Dental Co., Inc.1986-06-26440
K852926DENTOLOCK II DENTURE ADHESIVE CREAMSolar Dental Co., Inc.1985-08-23450
K831294SOLARCRY/TEMPORARY CROWN & BRIDGE MATSolar Dental Co., Inc.1983-08-311330
K831293SOLARCRYL CUSTOM TRAY MATERIALSolar Dental Co., Inc.1983-07-26970
K831265DENTOLOCK DENTURE ADHESIVE CREAMSolar Dental Co., Inc.1983-05-09210

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