Atlas FDA

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

Atlantis Components, Inc. — Predicate Candidate Screening

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

86 daysmedian FDA review time
213 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K103020ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTAtlantis Components, Inc.2011-02-031140
K073540ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANTAtlantis Components, Inc.2008-02-29730
K073258ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI AAtlantis Components, Inc.2008-02-14860
K072483ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLAtlantis Components, Inc.2007-11-16730
K071946ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRAAtlantis Components, Inc.2007-10-05840
K070833ATLANTIS ABUTMENT FOR ASTRA IMPLANTAtlantis Components, Inc.2007-06-22870
K063734ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACEAtlantis Components, Inc.2007-03-02740
K062197ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMIAtlantis Components, Inc.2007-02-282110
K062069ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANTAtlantis Components, Inc.2007-02-142080
K062277ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACEAtlantis Components, Inc.2006-12-201350
K053654ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACEAtlantis Components, Inc.2006-07-312130
K053373ATLANTIS ABUTMENT FOR ZIMMER INTERFACEAtlantis Components, Inc.2006-06-302070
K053450ATLANTIS ABUTMENT FOR ZIMMER INTERFACEAtlantis Components, Inc.2006-03-03810
K052070ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZAtlantis Components, Inc.2005-10-14740
K051652ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINIAtlantis Components, Inc.2005-07-22310
K051011ENDOSSEOUS DENTAL IMPLANT ABUTMENTAtlantis Components, Inc.2005-07-12820
K050052ATLANTIS ABUTMENT FOR STRAUMANN INTERFACEAtlantis Components, Inc.2005-03-07560
K981858ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREWAtlantis Components, Inc.1999-03-222990

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