Dental Device Guide
Add your company

Not currently registered with FDA under this name

Welch Allyn, Inc.

Skaneateles Falls, NY, United States. Named as applicant on 2 dental 510(k) clearances between 1977 and 1998. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
21977–1998
Markets registered in
173,972 registrations outside the US
Establishments
0—
1977: 11998: 119801990200020102020

510(k) clearances per year, 1976–2026

Registered in 17 markets

Where regulators' registries name Welch Allyn, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 2 clearancesColombia: 2,260 registrationsCanada: 689 registrationsEuropean Union: 331 registrationsSouth Korea: 179 registrationsSaudi Arabia: 131 registrationsCosta Rica: 109 registrationsTaiwan: 63 registrationsAustralia: 61 registrationsBrazil: 43 registrationsUnited Kingdom: 42 registrationsIsrael: 32 registrationsPeru: 17 registrationsChina: 8 registrationsHong Kong: 5 registrationsJapan: 1 registrationsSerbia: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantWelch Allyn, Inc.2 clearances1977–1998Below
ColombiaINVIMARegistration holderWELCH ALLYN INC2,260—Pure Global AI
CanadaHealth CanadaRegistration holderWELCH ALLYN, INC.WELCH ALLYN INC.6891998–2026Pure Global AI
European UnionEUDAMEDRegistration holderWelch Allyn, Inc.331—Pure Global AI
South KoreaMFDSManufacturerWelch Allyn, Inc.Welch Allyn Inc. · Welch Allyn · +21791998–2026Pure Global AI
Saudi ArabiaSFDAManufacturerWelch Allyn, Inc.Welch Allyn Ltd.131—Pure Global AI
Costa RicaMinisterio de SaludManufacturerWELCH ALLYN INCWelch Allyn · WELCH ALLYN, INC. · +1109—Pure Global AI
TaiwanTFDAManufacturerWELCH ALLYN INC.Welch Allyn, Inc. · WELCH ALLYN, INC.631981–2022Pure Global AI
AustraliaTGAManufacturerWelch Allyn IncWelch Allyn Incorporated612003–2026Pure Global AI
BrazilANVISAManufacturerWELCH ALLYN, INCWELCH ALLYN INC. · WELCH ALLYN, INC.432006–2023Pure Global AI
United KingdomMHRAManufacturerWelch Allyn, Inc.42—Pure Global AI
IsraelAMARManufacturerWelch Allyn Inc.Welch Allyn, Inc. · Welch Allyn, Inc · +232—Pure Global AI
PeruDIGEMIDManufacturerWELCH ALLYN, INCWELCH ALLYN INC · WELCH ALLYN INC. · +1172017–2025Pure Global AI
ChinaNMPARegistration holder伟伦（美国）股份有限公司Welch Allyn, Inc.伟伦（美国）股份有限公司WELCH ALLYN, INC. · 美国伟伦公司Welch Allyn, Inc.8—Pure Global AI
Hong KongMDDManufacturerWelch Allyn, Inc.Welch Allyn Limited · Welch Allyn, Inc52014–2026Pure Global AI
JapanPMDARegistration holderＷｅｌｃｈ　Ａｌｌｙｎ，　Ｉｎｃ．12014–2014Pure Global AI
SerbiaALIMSManufacturerWelch Allyn, Inc12024–2024Pure 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

510(k) clearances

Clearances on which FDA names Welch Allyn, Inc. as the applicant.

Decided510(k)DeviceDevice type
24 Aug 1998K981937WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEMEIA Operative Dental Unit
19 Aug 1977K771481TONGUE BLADE HOLDEREMA Dental Cement

Sources

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 of the most recent filing, which can be a US agent.