Schutz-Dental GmbH: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Schutz-Dental GmbH” (first 2005, latest 2015), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 86 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 | 1 | 476 |
| 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EIH | Powder, Porcelain | 1 | 1 |
Review panels
- Dental (5)
Most recent Schutz-Dental GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133268 | TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS | EBG | 2015-02-12 | 476 |
| K071010 | TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS | EIH | 2007-08-24 | 137 |
| K052073 | FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 | EBI | 2005-10-26 | 86 |
| K052189 | REVENEER CERAMIC REPAIR SYSTEM | KLE | 2005-10-17 | 67 |
| K051050 | SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 | KLE | 2005-06-29 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Schutz-Dental 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 Schutz-Dental GmbH?
FDA lists 5 510(k) clearances under the applicant name “Schutz-Dental GmbH” (first 2005, latest 2015), across 4 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 Schutz-Dental GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Schutz-Dental GmbH is 86 days.
Which FDA product codes appear under Schutz-Dental GmbH?
The most frequent FDA product codes under this applicant name are KLE (Agent, Tooth Bonding, Resin, 2); EBG (Crown And Bridge, Temporary, Resin, 1); EBI (Resin, Denture, Relining, Repairing, Rebasing, 1).
Next steps
- See all 5 Schutz-Dental GmbH clearances with predicates and recalls
- Run predicate analysis for product code KLE, Schutz-Dental 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.