Atlas FDA

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

Crown Delta Corp. — Predicate Candidate Screening

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

69 daysmedian FDA review time
269 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K122974TRYOUT-VPS HOLDING PASTECrown Delta Corp.2013-05-172330
K041028CROWN DELTA HYDROPHILIC IMPRESSION MATERIALCrown Delta Corp.2004-05-14230
K955288HEARING AID IMPRESSION MATERIALCrown Delta Corp.1996-02-02780
K940132PODIATRIC MATERIALCrown Delta Corp.1994-09-292690
K930248VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEMCrown Delta Corp.1994-01-073530
K926150VINYL ADDITION SILICONE SYSTEMCrown Delta Corp.1993-07-142190
K901991SILICONE ELASTOMER PUTTYCrown Delta Corp.1990-09-141350
K901990VINYL SILICONE ELASTOMER MATERIALCrown Delta Corp.1990-09-141350
K872745VINYL POLYSILOXANE IMPRESSION SYSTEMCrown Delta Corp.1987-07-2180
K871409VINYL POLYSILOXANE IMPRESSION SYSTEMCrown Delta Corp.1987-06-11640
K843145TWO COMPONENT RTV VINYL SILICONE MATERCrown Delta Corp.1984-10-18690
K821221DENTAL IMPRESSION MATERIALCrown Delta Corp.1982-06-07410
K801380CROWN DELTA SILICONE IMPRESSION MATERIALCrown Delta Corp.1980-07-08270
K781907EAR STOPPLES FOR NOISE ATTENTIONCrown Delta Corp.1978-11-2280
K781083DENTAL SILICONE IMPRESSION MATERIALCrown Delta Corp.1978-08-31630
K780391PODIATRIC MATERIALCrown Delta Corp.1978-06-14960
K780778RTV SILICONE HAND KNEADABLE PUTTYCrown Delta Corp.1978-05-31200
K760231IMPRESSION MATERIAL, DENTAL SILICON RTVCrown Delta Corp.1976-07-2170

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