Atlas FDA

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

Rocky Mountain Orthodontics, Inc. · Predicate Candidate Screening

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

41 daysmedian FDA review time
88 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K895401NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEMRocky Mountain Orthodontics, Inc.1989-12-04880
K843527ORTHOMITE 111 ADHESIVERocky Mountain Orthodontics, Inc.1984-10-18410
K780678IMPRESSION TRAYRocky Mountain Orthodontics, Inc.1978-04-2840
K780334ADHESIVE, BRACKET AND CONDITIONER RESINRocky Mountain Orthodontics, Inc.1978-03-28280
K780170ORTHODONTIC BRACKET PADSRocky Mountain Orthodontics, Inc.1978-03-15410
K780205ORTHODONTIC BUCCAL TUBERocky Mountain Orthodontics, Inc.1978-02-1690

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