Atlas FDA

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

Premium Plus International Limited · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K170261Premium Plus Prophy Air MotorPremium Plus International Limited2017-10-192650
K163447Premium Plus Disposable Barrier SleevePremium Plus International Limited2017-06-201940
K153514Premium Plus C01/C02 LED Curing LightPremium Plus International Limited2016-08-222590
K100854PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399Premium Plus International Limited2010-12-092580

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