Atlas FDA

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

Macdonald Metals and Ceramics — Predicate Candidate Screening

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

26 daysmedian FDA review time
26 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K891530M-77 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-14280
K891516C-89 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-14280
K891519C-86 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891527M-60 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891528M-65 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891522M-4 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891525M-46 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891517C-63 GOLD BAE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891521M-1 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891529M-W SILVER PALLADIUM BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891533M-74 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891524M-40 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891535P-C PALLADIUM BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891531M-50 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891534M-75 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891523M-20 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891514C-5 PALLADIUM BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891520C-87 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891518C-76 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891532M-70 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-12260
K891515C-52 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-07210
K891526M-56 GOLD BASE DENTAL ALLOYMacdonald Metals and Ceramics1989-04-07210

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