Innovative Bioceramix, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Innovative Bioceramix, Inc.” (first 2006, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 42 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 | 1 | 588 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 55 |
| 2023 | 1 | 30 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Innovative Bioceramix, Inc. took a median 42 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | 8 | 8 |
Review panels
- Dental (8)
Most recent Innovative Bioceramix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231259 | iRoot SP Plus | KIF | 2023-05-31 | 30 |
| K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material | KIF | 2022-11-22 | 55 |
| K130312 | IROOT FM | KIF | 2014-09-18 | 588 |
| K102867 | IROOT FS | KIF | 2010-12-03 | 64 |
| K092715 | IROOT BP PLUS | KIF | 2009-09-28 | 25 |
| K082943 | IROOT BP, MODEL IRBP 4609 | KIF | 2009-01-06 | 96 |
| K080917 | IROOT SP | KIF | 2008-04-09 | 8 |
| K063422 | BIOAGGREGATE | KIF | 2006-11-21 | 8 |
Recalls
openFDA lists no recalls under a recalling firm named Innovative Bioceramix, 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.
- Innovative Health, LLC (50 510(k)s)
- Innovative Medical Systems, Inc. (22 510(k)s)
- Innovative Technologies , Ltd. (14 510(k)s)
- Innovative Surgical Products, Inc. (12 510(k)s)
- Innovative Diagnostic Systems, Inc. (11 510(k)s)
- Innovative Gloves Co;, Ltd. (9 510(k)s)
- Innovative Surgical Designs, Inc. (9 510(k)s)
- Innovative Surgical, Inc. (7 510(k)s)
- Innovative Medical Technologies, Inc. (6 510(k)s)
- Innovative Spinal Technologies, Inc. (4 510(k)s)
- Innovative Therapies, Inc. (4 510(k)s)
- Innovative Trauma Care, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Innovative Bioceramix, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Innovative Bioceramix, Inc.” (first 2006, latest 2023), across 1 product code 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 Innovative Bioceramix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innovative Bioceramix, Inc. is 42 days.
Which FDA product codes appear under Innovative Bioceramix, Inc.?
The most frequent FDA product codes under this applicant name are KIF (Resin, Root Canal Filling, 8).
Next steps
- See all 8 Innovative Bioceramix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KIF, Innovative Bioceramix, 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.