Atlantis Components, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Atlantis Components, Inc.” (first 1999, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 85 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 17 | 17 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
Review panels
- Dental (18)
Most recent Atlantis Components, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103020 | ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT | NHA | 2011-02-03 | 114 |
| K073540 | ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT | NHA | 2008-02-29 | 73 |
| K073258 | ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT | NHA | 2008-02-14 | 86 |
| K072483 | ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS | NHA | 2007-11-16 | 73 |
| K071946 | ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS | NHA | 2007-10-05 | 84 |
| K070833 | ATLANTIS ABUTMENT FOR ASTRA IMPLANT | NHA | 2007-06-22 | 87 |
| K063734 | ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE | NHA | 2007-03-02 | 74 |
| K062197 | ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+ ABUTMENT | NHA | 2007-02-28 | 211 |
| K062069 | ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT | NHA | 2007-02-14 | 208 |
| K062277 | ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE | NHA | 2006-12-20 | 135 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Atlantis Components, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Atlantis Diagnostics Intl., Inc. (3 510(k)s)
- Atlantis Luminescent Products, LLC (1 510(k)s)
- Atlantis Scientific Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Atlantis Components, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Atlantis Components, Inc.” (first 1999, latest 2011), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Atlantis Components, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Atlantis Components, Inc. is 85 days.
Which FDA product codes appear under Atlantis Components, Inc.?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 17); DZE (Implant, Endosseous, Root-Form, 1).
Next steps
- See all 18 Atlantis Components, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NHA, Atlantis Components, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.