Manufacturer registered with FDA

Kwang Myung Daicom, Inc.

SEOUL, South Korea. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9097899ManufacturerRepacker / relabeler
Device types listed
3
Brands and models
3
510(k) clearances
12011–2011
Markets registered in
1United States
Establishments
1South Korea
2011: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Kwang Myung Daicom, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Orthodontic Extraoral HeadgearDZB · Class 2Retainers, expanders & headgearMaker
Headgear
2011
Mouth MirrorEAX · Class 1Dental hand instrumentsLister
Mirror
2007
Orthodontic Ligature Tucking InstrumentECP · Class 1Dental hand instrumentsLister
Instrument
2007

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Kwang Myung Daicom, Inc. as the applicant.

Decided510(k)DeviceDevice type
3 Oct 2011K111169PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMFDZB Orthodontic Extraoral Headgear

Some of these clearances are listed with FDA today by another company: G&H Wire Company (1).

Registered establishments

EstablishmentLocationWhat it does
KWANG MYUNG DAICOM LTD.FDA reg. 3004077103SEOUL, South KoreaManufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9097899). 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.