Registered with FDA

Sontec Instruments Inc

Centennial, CO, United States. Lists 17 dental device types with FDA across 1 registered establishment.

FDA owner/operator1720747Repacker / relabeler
Device types listed
17
Brands and models
17
510(k) clearances
0as applicant
Markets registered in
62,111 registrations outside the US
Establishments
1United States

Registered in 6 markets

Where regulators' registries name Sontec Instruments Inc as the manufacturer or the registration holder of a device.

All markets
United States: 17 device types listedThailand: 2,004 registrationsSouth Korea: 98 registrationsTaiwan: 6 registrationsColombia: 2 registrationsIsrael: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAListerSontec Instruments Inc17 device types—Below
ThailandThai FDAManufacturerSONTEC INSTRUMENTS, INC.2,004—Pure Global AI
South KoreaMFDSManufacturerSontec Instruments,IncSontec Instruments,Inc. · Sontec Instruments.Inc · +2982011–2026Pure Global AI
TaiwanTFDAManufacturerSONTEC INSTRUMENTS, INC.SONTEC INSTRUMENTS INC.62006–2013Pure Global AI
ColombiaINVIMAManufacturerSONTEC INSTRUMENTS INC2—Pure Global AI
IsraelAMARManufacturerSontec Instruments Inc1—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 Sontec Instruments Inc currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental Hand InstrumentsDZN · Class 1Dental hand instrumentsLister
Multiple
2013
Dental Surgical Tissue ScissorsEGN · Class 1Dental hand instrumentsLister
SCISSORS, SURGICAL TISSUE, DENTAL
2017
All Types RetractorEIG · Class 1Dental hand instrumentsLister
ALL TYPES OF RETRACTORS
1992
Periodontic ProbeEIX · Class 1Dental hand instrumentsLister
PROBE, PERIODONTIC
2019
Operative Dental ExcavatorEKC · Class 1Dental hand instrumentsLister
EXCAVATOR, DENTAL, OPERATIVE
2017
Operative Amalgam and Foil CondenserEKG · Class 1Dental hand instrumentsLister
Multiple
2014
Operative Dental Amalgam CarverEKH · Class 1Dental hand instrumentsLister
Multiple
2014
Operative BurnisherEKJ · Class 1Dental hand instrumentsLister
Multiple
2014
Surgical HemostatEMD · Class 1Dental hand instrumentsLister
MULTIPLE
1992
Surgical Tooth Extractor ForcepsEMG · Class 1Dental hand instrumentsLister
multiple
2014
Surgical Rongeur ForcepsEMH · Class 1Dental hand instrumentsLister
MULTIPLE
2012
Surgical Bone FileEMI · Class 1Dental hand instrumentsLister
Multiple
2014
Dental Surgical ElevatorEMJ · Class 1Dental hand instrumentsLister
MULTIPLE
2010
Dental Surgical CuretteEMK · Class 1Dental hand instrumentsLister
MULTIPLE
2012
Surgical Osteotome ChiselEMM · Class 1Dental hand instrumentsLister
multiple
2012
Periodontic ScalerEMN · Class 1Dental hand instrumentsLister
MULTIPLE
1992
Periodontic FileEMR · Class 1Dental hand instrumentsLister
FILE, PERIODONTIC
2019

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
SONTEC INSTRUMENTS, INC.FDA reg. 1720747CENTENNIAL, CO, United StatesRepacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1720747). 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.