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

Astra Tech, Inc. — Predicate Candidate Screening

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

109 daysmedian FDA review time

179 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days
K122078	LOFRIC PRIMO, LOFRIC HYDRO-KIT	Astra Tech, Inc.	2012-10-31	107
K120338	ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS	Astra Tech, Inc.	2012-07-05	153
K113003	ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KE	Astra Tech, Inc.	2012-03-01	146
K112138	ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS	Astra Tech, Inc.	2011-12-01	128
K110640	ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LA	Astra Tech, Inc.	2011-06-10	98
K110356	ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT	Astra Tech, Inc.	2011-06-10	123
K103759	ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPL	Astra Tech, Inc.	2011-04-08	106
K101004	ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEM	Astra Tech, Inc.	2010-08-16	126
K093780	ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUT	Astra Tech, Inc.	2010-04-16	128
K093483	ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS	Astra Tech, Inc.	2009-12-22	43
K091920	ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR	Astra Tech, Inc.	2009-09-28	90
K083871	ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRA	Astra Tech, Inc.	2009-04-15	107
K081666	ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR AS	Astra Tech, Inc.	2008-10-07	116
K063779	OSSEOSPEED 4.0S-6MM, MODEL 24619	Astra Tech, Inc.	2007-04-27	127
K053384	FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TE	Astra Tech, Inc.	2006-03-24	109
K050874	ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER	Astra Tech, Inc.	2005-05-05	29
K043241	LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER	Astra Tech, Inc.	2004-12-23	30
K041492	ASTRA TECH IMPLANTS - DENTAL SYSTEM	Astra Tech, Inc.	2004-08-09	66
K024111	ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED	Astra Tech, Inc.	2003-06-10	179
K023631	ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS	Astra Tech, Inc.	2002-11-07	9
K012374	MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER	Astra Tech, Inc.	2001-08-23	28
K002513	ASTRA TECH IMPLANTS - DENTAL SYSTEM	Astra Tech, Inc.	2001-01-04	142
K990304	MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM	Astra Tech, Inc.	1999-07-15	164
K991053	ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACR	Astra Tech, Inc.	1999-06-25	87
K974738	ASTRA TECH IMPLANT DENTAL SYSTEM	Astra Tech, Inc.	1998-11-19	335
K974737	ASTRA TECH IMPLANT DENTAL SYSTEM	Astra Tech, Inc.	1998-03-24	95
K980698	ASTRA TECH IMPLANTS - DENTAL SYSTEM	Astra Tech, Inc.	1998-03-19	24
K931767	ASTRA TECH IMPLANTS-DENTAL SYSTEM	Astra Tech, Inc.	1994-02-08	306

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