Davis Schottlander & Davis, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Davis Schottlander & Davis, Ltd.” (first 1996, latest 2004), 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 | 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
| EIH | Powder, Porcelain | 2 | 2 |
| ELM | Denture, Plastic, Teeth | 2 | 2 |
| ELL | Teeth, Porcelain | 1 | 1 |
Review panels
- Dental (7)
Most recent Davis Schottlander & Davis, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K024252 | MATCH MASTER LOW FUSION PORCELAIN | EIH | 2004-01-22 | 395 |
| K024250 | MATCH PRESS PRESSABLE CERAMIC | EIH | 2003-08-25 | 245 |
| K001463 | SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 | EBI | 2000-06-16 | 37 |
| K993717 | ENIGMA HI-BASE DENTURE BASE MATERIAL | EBI | 1999-12-22 | 49 |
| K984134 | NATURA DENTURE TEETH | ELM | 1999-02-12 | 86 |
| K984128 | ENIGMA DENTURE TEETH | ELM | 1999-02-09 | 83 |
| K960770 | MATCHMAKER/PROPAQUE PORCELAIN | ELL | 1996-11-19 | 267 |
Recalls
openFDA lists no recalls under a recalling firm named Davis Schottlander & Davis, Ltd..
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.
- Davis & Geck, Inc. (45 510(k)s)
- Davis Lead Aprons, Inc. (3 510(k)s)
- Davis Assoc. (1 510(k)s)
- Davis Medical (1 510(k)s)
- Davis Positioning Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Davis Schottlander & Davis, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Davis Schottlander & Davis, Ltd.” (first 1996, latest 2004), 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 Davis Schottlander & Davis, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Davis Schottlander & Davis, Ltd. is 86 days.
Which FDA product codes appear under Davis Schottlander & Davis, Ltd.?
The most frequent FDA product codes under this applicant name are EBI (Resin, Denture, Relining, Repairing, Rebasing, 2); EIH (Powder, Porcelain, 2); ELM (Denture, Plastic, Teeth, 2).
Next steps
- See all 7 Davis Schottlander & Davis, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBI, Davis Schottlander & Davis, Ltd.'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.