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

Nobel Biocare AB — Predicate Candidate Screening

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

115 daysmedian FDA review time

270 days90th percentile

93clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253999	Universal Base ASC Engaging; Universal Base ASC Non-Engaging	Nobel Biocare AB	2026-08-06	234	0
K252197	Nobel Biocare S Series Implants	Nobel Biocare AB	2026-02-18	219	0
K243834	NobelZygoma TiUltra Implant system	Nobel Biocare AB	2025-08-25	255	0
K240346	NobelProcera Zirconia Implant Bridge	Nobel Biocare AB	2025-01-03	333	0
K233208	NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw	Nobel Biocare AB	2024-01-24	118	0
K231898	DTX Studio Clinic (4.0)	Nobel Biocare AB	2023-12-08	163	0
K223677	Titanium Abutment Blank Nobel Biocare N1 TCC	Nobel Biocare AB	2023-04-28	141	0
K221921	DTX Studio Clinic 3.0	Nobel Biocare AB	2023-03-28	270	0
K213562	DTX Studio Clinic 3.0	Nobel Biocare AB	2022-03-25	136	0
K202452	NobelProcera Zirconia Implant Bridge	Nobel Biocare AB	2020-12-03	98	0
K203156	DTX Studio Clinic	Nobel Biocare AB	2020-11-20	29	0
K202344	TiUltra Implants and Xeal Abutments	Nobel Biocare AB	2020-11-16	90	0
K200810	IPS CaseDesigner	Nobel Biocare AB	2020-10-08	195	0
K191475	Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plat	Nobel Biocare AB	2019-08-29	86	0
K181932	DTX Studio design	Nobel Biocare AB	2019-03-01	225	0
K173418	NobelParallel Conical Connection	Nobel Biocare AB	2019-02-21	477	1
K181869	On1 Universal Abutment	Nobel Biocare AB	2018-12-12	153	0
K183069	NobelZygoma 0°	Nobel Biocare AB	2018-12-04	29	0
K180899	Universal Base Abutment	Nobel Biocare AB	2018-10-31	208	0
K181075	PureSet Tray	Nobel Biocare AB	2018-09-27	156	0
K163600	Kit Boxes and Kit Plates	Nobel Biocare AB	2018-01-22	397	0
K172224	DTX Studio diagnose	Nobel Biocare AB	2018-01-11	170	0
K172854	NobelPerfect Abutments	Nobel Biocare AB	2017-12-14	85	0
K171466	NobelDesign, DTX Studio Design	Nobel Biocare AB	2017-11-29	195	0
K171142	Healing Cap Multi-Unit Titanium	Nobel Biocare AB	2017-10-26	191	0
K172352	TREFOIL System	Nobel Biocare AB	2017-10-20	78	0
K170135	TREFOIL System	Nobel Biocare AB	2017-05-11	114	0
K161416	Multi-unit Abutment Plus	Nobel Biocare AB	2017-03-16	297	0
K161598	NobelZygoma 0°	Nobel Biocare AB	2017-03-14	278	0
K161655	On1 Concept	Nobel Biocare AB	2017-02-28	257	0
K163122	NobelClinician, DTX Studio implant	Nobel Biocare AB	2017-01-31	84	0
K162043	NobelProcera HT ML FCZ Bridge	Nobel Biocare AB	2016-11-22	120	0
K161435	Temporary Snap Abutment	Nobel Biocare AB	2016-11-22	182	0
K161634	IPS CaseDesigner	Nobel Biocare AB	2016-11-10	149	0
K160158	NobelProcera HT ML FCZ Implant Bridge and Framework	Nobel Biocare AB	2016-07-25	180	0
K153534	NobelProcera HT ML Full Contour Zirconia Crown	Nobel Biocare AB	2016-06-06	180	0
K160119	NobelSpeedy Groovy	Nobel Biocare AB	2016-06-02	135	0
K153036	NobelDesign Software	Nobel Biocare AB	2016-06-02	227	0
K152836	TREFOIL System	Nobel Biocare AB	2016-04-11	195	0
K152093	NobelZygoma 45°	Nobel Biocare AB	2016-03-16	232	0
K142260	NobelActive	Nobel Biocare AB	2015-05-11	270	0
K133731	NOBELACTIVE WIDE PLATFORM (WP)	Nobel Biocare AB	2014-05-08	153	0
K133377	NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE	Nobel Biocare AB	2014-04-04	151	0
K120954	NOBELPROCERA PEEK ABUTMENTS	Nobel Biocare AB	2013-06-05	432	0
K123976	NOBELCLINICIAN	Nobel Biocare AB	2013-03-26	90	0
K122602	NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS	Nobel Biocare AB	2013-03-13	198	0
K112259	NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS	Nobel Biocare AB	2011-10-28	81	0
K111581	15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABU	Nobel Biocare AB	2011-06-23	16	0
K102436	NOBEL ACTIVE 3.0	Nobel Biocare AB	2010-12-09	105	0
K101714	NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS	Nobel Biocare AB	2010-08-31	74	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