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

Nobel Biocare USA, LLC · Predicate Candidate Screening

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

71 daysmedian FDA review time

324 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K132749	NOBELPROCERA OVERDENTURE BAR	Nobel Biocare USA, LLC	2014-07-24	324	0
K132746	NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNEC	Nobel Biocare USA, LLC	2014-01-30	149	0
K110171	NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS	Nobel Biocare USA, LLC	2011-06-15	146	0
K083100	GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGI	Nobel Biocare USA, LLC	2008-11-19	30	0
K073142	NOBELREPLACE HEXAGONAL IMPLANT	Nobel Biocare USA, LLC	2008-01-11	65	0
K062566	NOBELREPLACE TAPERED CONICAL CONNECTION	Nobel Biocare USA, LLC	2006-12-06	97	27
K052885	ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17	Nobel Biocare USA, LLC	2005-12-23	71	0
K050641	ZYGOMA TIUNITE	Nobel Biocare USA, LLC	2005-04-07	24	0
K043312	NOBELRONDO DENTAL CERAMIC - ZIRCONIA	Nobel Biocare USA, LLC	2005-02-01	62	0

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