Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

European Dental Imports, Inc. · Predicate Candidate Screening

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

61 daysmedian FDA review time
70 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K982129ANTAGON PORCELAINEuropean Dental Imports, Inc.1998-08-04480
K981001ORION VESTA DENTAL ALLOYEuropean Dental Imports, Inc.1998-05-18610
K981002ORION WX DENTAL ALLOYEuropean Dental Imports, Inc.1998-05-18610
K981000CARRARA PORCELAIN AND CARRARA VINCENT PORCELAINEuropean Dental Imports, Inc.1998-05-15580
K980661CERA E DENTAL ALLOYEuropean Dental Imports, Inc.1998-05-01700
K980660BIOGOLD PLUS DENTAL ALLOYEuropean Dental Imports, Inc.1998-04-27660
K980597CARRARA PDF, CARRARA H, CARRARA REuropean Dental Imports, Inc.1998-03-09200

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