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

North Pacific Dental, Inc. · Predicate Candidate Screening

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

49 daysmedian FDA review time

72 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K830113	SEPTOPACK	North Pacific Dental, Inc.	1983-05-09	118
K830111	SEPTOCAL	North Pacific Dental, Inc.	1983-03-24	72
K830106	UNICIDE	North Pacific Dental, Inc.	1983-03-07	55
K830105	VITATHYL	North Pacific Dental, Inc.	1983-03-01	49
K830114	GUTTA PERCHA POINTS	North Pacific Dental, Inc.	1983-03-01	49
K830117	ENDOMET	North Pacific Dental, Inc.	1983-03-01	49
K830109	CIMPAT	North Pacific Dental, Inc.	1983-03-01	49
K830115	PAPER POINTS	North Pacific Dental, Inc.	1983-03-01	49
K830112	HYDROL	North Pacific Dental, Inc.	1983-02-18	38
K830107	SELFAST	North Pacific Dental, Inc.	1983-02-18	38
K830116	SULCARINGS	North Pacific Dental, Inc.	1983-02-18	38

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