Atlas FDA

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

Macrochem Corp. · Predicate Candidate Screening

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

69 daysmedian FDA review time
190 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K890623FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENTMacrochem Corp.1989-04-17690
K890608FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENTMacrochem Corp.1989-04-17700
K890494FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFSMacrochem Corp.1989-03-29570
K880562ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KITMacrochem Corp.1988-08-191900
K861546REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KITMacrochem Corp.1986-05-21260

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