Manufacturer registered with FDA
Davis Schottlander & Davis, Ltd.
LETCHWORTH, United Kingdom. Lists 3 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 71996–2004
- Markets registered in
- 78,559 registrations outside the US
- Establishments
- 1United Kingdom
510(k) clearances per year, 1990–2026
Registered in 7 markets
Where regulators' registries name Davis Schottlander & Davis, Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Davis Schottlander & Davis, Ltd. | 7 clearances | 1996–2004 | Below |
| European Union | EUDAMED | Registration holder | Davis Schottlander & Davis LtdDavis Schottlander & Davis Limited | 8,466 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | DAVIS SCHOTTLANDER & DAVIS LIMITED | 64 | 2000–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Davis Schottlander & Davis Ltd | 23 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DAVIS SCHOTTLANDER & DAVIS LTDDavis Schottlander & Davis Limited · Davis Schottlander & Davis Ltd | 3 | 2006–2014 | Pure Global AI |
| Australia | TGA | Manufacturer | Davis Schottlander & Davis Ltd | 2 | 2004–2019 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Davis Schottlander&Davis Ltd. | 1 | 2007–2007 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Davis Schottlander & Davis, Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | — | 2007 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | — | 2007 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | — | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Davis Schottlander & Davis, Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Jan 2004 | K024252 | MATCH MASTER LOW FUSION PORCELAIN | EIH Porcelain Powder |
| 25 Aug 2003 | K024250 | MATCH PRESS PRESSABLE CERAMIC | EIH Porcelain Powder |
| 16 Jun 2000 | K001463 | SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 | EBI Rebasing Repairing Relining Denture Resin |
| 22 Dec 1999 | K993717 | ENIGMA HI-BASE DENTURE BASE MATERIAL | EBI Rebasing Repairing Relining Denture Resin |
| 12 Feb 1999 | K984134 | NATURA DENTURE TEETH | ELM Teeth Plastic Denture |
| 9 Feb 1999 | K984128 | ENIGMA DENTURE TEETH | ELM Teeth Plastic Denture |
| 19 Nov 1996 | K960770 | MATCHMAKER/PROPAQUE PORCELAIN | ELL Porcelain Teeth |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DAVIS SCHOTTLANDER & DAVIS, LTD.FDA reg. 9681531 | LETCHWORTH, HERTS. Hertfordshire, United Kingdom | Foreign exporter, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9024615). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.