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

Itena Clinical · Predicate Candidate Screening

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

263 daysmedian FDA review time

304 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K170207	Obturys	Itena Clinical	2017-07-31	188
K162960	TotalC-Ram	Itena Clinical	2017-03-14	141
K122551	PROVITEMP	Itena Clinical	2013-06-14	297
K122521	PREVENT SEAL	Itena Clinical	2013-06-11	295
K122549	DENTO TEMP	Itena Clinical	2013-04-26	248
K121804	PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM	Itena Clinical	2013-04-19	304
K122522	DENTOETCH QUICKBOND BOND ACTIVATOR	Itena Clinical	2013-03-19	211
K121769	DENTOCORE / DENTOCORE BODY	Itena Clinical	2013-03-05	263

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