Manufacturer registered with FDA

Encore Medical LP

Austin, TX, United States. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator9002203Manufacturer
Device types listed
1
Brands and models
2
510(k) clearances
0as applicant
Markets registered in
4103 registrations outside the US
Establishments
1United States

Registered in 4 markets

Where regulators' registries name Encore Medical LP as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedUnited Kingdom: 79 registrationsAustralia: 20 registrationsColombia: 4 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerEncore Medical LP1 device types—Below
United KingdomMHRAManufacturerEncore Medical L.P.Encore Medical79—Pure Global AI
AustraliaTGAManufacturerEncore Medical LP202011–2026Pure Global AI
ColombiaINVIMAManufacturerENCORE MEDICAL, L.P.ENCORE MEDICAL, LP.4—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 Encore Medical LP currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Surgical Bone ChiselEML · Class 1Dental hand instrumentsMaker
ENCORE CHISELFEMORAL CUTTING CHISEL
2006

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
ENCORE MEDICAL, L.P.FDA reg. 1644408AUSTIN, TX, United StatesManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9002203). 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.