Manufacturer registered with FDA

Platts and Nisbett Ltd.

Sheffield, United Kingdom. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10039777Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
361 registrations outside the US
Establishments
1United Kingdom

Registered in 3 markets

Where regulators' registries name Platts and Nisbett Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedUnited Kingdom: 35 registrationsAustralia: 26 registrations
RegisteredHome: United KingdomOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerPlatts and Nisbett Ltd.1 device types—Below
United KingdomMHRAManufacturerPlatts & Nisbett35—Pure Global AI
AustraliaTGAManufacturerPlatts & Nisbett Ltd262010–2026Pure 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 Platts and Nisbett Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Periodontic ScalerEMN · Class 1Dental hand instrumentsMaker
PLATTS & NISBETT
2012

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

EstablishmentLocationWhat it does
PLATTS AND NISBETT LTD.FDA reg. 3003694247Sheffield, United KingdomManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10039777). 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.