Dental Device Guide
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Manufacturer registered with FDA

Dale Medical Products Inc

New London, CT, United States. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator1214422Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
12173 registrations outside the US
Establishments
1United States

Registered in 12 markets

Where regulators' registries name Dale Medical Products Inc as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedColombia: 59 registrationsEuropean Union: 43 registrationsUnited Kingdom: 21 registrationsCosta Rica: 16 registrationsTaiwan: 13 registrationsSouth Korea: 10 registrationsAustralia: 5 registrationsSerbia: 3 registrationsCanada: 1 registrationsIsrael: 1 registrationsPeru: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerDale Medical Products Inc1 device types—Below
ColombiaINVIMARegistration holderDALE MEDICAL PRODUCTS, INC.59—Pure Global AI
European UnionEUDAMEDManufacturerDale Medical Products, Inc.43—Pure Global AI
United KingdomMHRAManufacturerDale Medical Products21—Pure Global AI
Costa RicaMinisterio de SaludManufacturerDale Medical Products, Inc.DALE MEDICAL PRODUCTS, INC.16—Pure Global AI
TaiwanTFDAManufacturerDALE MEDICAL PRODUCTS, INC.DALE MEDICAL PRODUCTS INC. · Dale Medical Products, Inc.132005–2026Pure Global AI
South KoreaMFDSManufacturerDale Medical Products, Inc.102001–2016Pure Global AI
AustraliaTGAManufacturerDale Medical Products Inc52004–2025Pure Global AI
SerbiaALIMSManufacturerDale Medical Products, Inc.32026–2026Pure Global AI
CanadaHealth CanadaRegistration holderDALE MEDICAL PRODUCTS, INC.12012–2012Pure Global AI
IsraelAMARManufacturerDale Medical Products Inc.1—Pure Global AI
PeruDIGEMIDManufacturerDALE MEDICAL PRODUCTS, INC.12024–2024Pure 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 Dale Medical Products Inc currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Tongue ScraperLCN · Class 1—Maker
DALE SCRAPE-N-SUCTION TONGUE CLEANER
2024

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
DALE MEDICAL PRODUCTS, INC.FDA reg. 1214422New London, CT, United StatesManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1214422). 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.