Manufacturer registered with FDA

Chaplet International (Pvt) Ltd

Lahore, Pakistan. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10051298Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
421 registrations outside the US
Establishments
1Pakistan

Registered in 4 markets

Where regulators' registries name Chaplet International (Pvt) Ltd as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedEuropean Union: 17 registrationsAustralia: 2 registrationsTaiwan: 2 registrations
RegisteredHome: PakistanOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerChaplet International (Pvt) Ltd1 device types—Below
European UnionEUDAMEDManufacturerChaplet International Pvt Ltd17—Pure Global AI
AustraliaTGAManufacturerChaplet International Pvt Ltd22015–2018Pure Global AI
TaiwanTFDAManufacturerCHAPLET INTERNATIONAL (PVT) LIMITEDChaplet International (Pvt.) Ltd.22016–2025Pure 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 Chaplet International (Pvt) Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Shellac Base PlateEEA · Class 1—Maker
PLATE, BASE, SHELLAC
2016

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
CHAPLET INTERNATIONALFDA reg. 3003998824Lahore Punjab, PakistanManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10051298). 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.