Manufacturer registered with FDA
Oxford Performance Materials, Inc.
South Windsor, CT, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Oxford Performance Materials, Inc. 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 | Oxford Performance Materials, Inc. | 1 device types | — | Below |
| Israel | AMAR | Manufacturer | Oxford Performance Materials, Inc | 1 | — | 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 Oxford Performance Materials, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Pekkton® Ivory Milling blank 95/t12mmPekkton® Ivory Milling blank 95/t16mmPekkton® Ivory Milling blank 95/t20mmPekkton® Ivory Milling blank 95/t25mmPekkton® Ivory Milling blank 95/t30mmPekkton® Ivory Milling blank 98.5/t12mmPekkton® Ivory Milling blank 98.5/t16mmPekkton® Ivory Milling blank 98.5/t20mmPekkton® Ivory Milling blank 98.5/t24mmPekkton® Ivory Milling blank 98.5/t28mm | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OXFORD PERFORMANCE MATERIALS, INC.FDA reg. 3009582362 | South Windsor, CT, United States | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043473). 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.