Imz, GmbH: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Imz, GmbH” (first 1995, latest 1997), across 1 product code in 1 review panel. Median 510(k) review time under this name: 113 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 12 | 12 |
Review panels
- Dental (12)
Most recent Imz, GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963520 | IMZ TWIN PLUS SCREW | DZE | 1997-08-12 | 343 |
| K963521 | IMZ TWIN PLUS - CYLINDER | DZE | 1997-08-06 | 337 |
| K963522 | IMZ 2000 INTERLOCK 12/3 - SCREW | DZE | 1997-03-03 | 181 |
| K963495 | IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM | DZE | 1997-03-03 | 181 |
| K951611 | IMZ - DENTAL IMPLANT SINGLE TOOTH ATTACHMENT | DZE | 1995-08-01 | 116 |
| K951609 | IMZ - DENTAL IMPLANT SURGICAL TRAY | DZE | 1995-08-01 | 116 |
| K951618 | IMZ - DENTAL IMPLANT O-RING ATTACHMENT | DZE | 1995-07-26 | 110 |
| K951617 | IMZ - DENTAL IMPLANT CASTABLE CSR ATTACHMENT | DZE | 1995-07-26 | 110 |
| K951615 | IMZ - DENTAL IMPLANT COMPONENTS | DZE | 1995-07-26 | 110 |
| K951614 | IMZ - DENTAL IMPLANT | DZE | 1995-07-26 | 110 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Imz, GmbH.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Imz, GmbH?
FDA lists 12 510(k) clearances under the applicant name “Imz, GmbH” (first 1995, latest 1997), 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 Imz, GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imz, GmbH is 113 days.
Which FDA product codes appear under Imz, GmbH?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 12).
Next steps
- See all 12 Imz, GmbH clearances with predicates and recalls
- Run predicate analysis for product code DZE, Imz, GmbH'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.