Atlas FDA

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

The S. S. White Co. — Predicate Candidate Screening

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

28 daysmedian FDA review time
50 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K852744CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLORThe S. S. White Co.1985-08-16500
K852745PORCELAIN VENEER SYSTEM BONDING KITThe S. S. White Co.1985-08-16500
K853005S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARMThe S. S. White Co.1985-08-13280
K852743PORCELAIN VENEER SYSTEM LABORATORY KITThe S. S. White Co.1985-07-31340
K852182EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATERThe S. S. White Co.1985-07-02430
K837440UNKNOWNThe S. S. White Co.1983-06-10660
K827816PODIATRY X-RAY UNITThe S. S. White Co.1982-08-24290
K781293RESTORATIVE SYSTEM PROFILEThe S. S. White Co.1978-08-18220
K771938ALGINATE IMPRESSION MATERIALThe S. S. White Co.1977-11-02160
K770093DENTAL BURSThe S. S. White Co.1977-01-2470
K760369POWDERLITEThe S. S. White Co.1976-08-1170
K760321CHAIR, DENTAL OPERATIVEThe S. S. White Co.1976-08-0380
K760323X-RAY UNIT, DENTAL DIAGNOSTICThe S. S. White Co.1976-08-0380
K760322CHAIR, ATTACHED INSTRUMENT DEL. SYS.The S. S. White Co.1976-08-0380

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