Manufacturer registered with FDA
HT Co., Ltd.
Yongin-si, South Korea. Lists 7 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 7
- Brands and models
- 147
- 510(k) clearances
- 12011–2011
- Markets registered in
- 1United States
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Devices listed with FDA
What HT Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | MISO NiTi Dimpled Archwire MDL-14MISO NiTi Dimpled Archwire MDL-16MISO NiTi Dimpled Archwire MDL-1616MISO NiTi Dimpled Archwire MDL-1622MISO NiTi Dimpled Archwire MDL-1725MISO NiTi Dimpled Archwire MDL-18MISO NiTi Dimpled Archwire MDL-1825MISO NiTi Dimpled Archwire MDL-1925MISO NiTi Dimpled Archwire MDU-14MISO NiTi Dimpled Archwire MDU-16 105 moreMISO NiTi Dimpled Archwire MDU-1616MISO NiTi Dimpled Archwire MDU-1622MISO NiTi Dimpled Archwire MDU-1725MISO NiTi Dimpled Archwire MDU-18MISO NiTi Dimpled Archwire MDU-1825MISO NiTi Dimpled Archwire MDU-1925MISO NiTi Reverse Curve MRL-14MISO NiTi Reverse Curve MRL-16MISO NiTi Reverse Curve MRL-1622MISO NiTi Reverse Curve MRL-1725MISO NiTi Reverse Curve MRL-18MISO NiTi Reverse Curve MRL-1825MISO NiTi Reverse Curve MRL-1925MISO NiTi Reverse Curve MRU-14MISO NiTi Reverse Curve MRU-16MISO NiTi Reverse Curve MRU-1622MISO NiTi Reverse Curve MRU-1725MISO NiTi Reverse Curve MRU-18MISO NiTi Reverse Curve MRU-1825MISO NiTi Reverse Curve MRU-1925MISO NiTi Superelastic Archwire MSL-10MISO NiTi Superelastic Archwire MSL-12MISO NiTi Superelastic Archwire MSL-14MISO NiTi Superelastic Archwire MSL-16MISO NiTi Superelastic Archwire MSL-1616MISO NiTi Superelastic Archwire MSL-1622MISO NiTi Superelastic Archwire MSL-1725MISO NiTi Superelastic Archwire MSL-18MISO NiTi Superelastic Archwire MSL-1825MISO NiTi Superelastic Archwire MSL-1925MISO NiTi Superelastic Archwire MSL-20MISO NiTi Superelastic Archwire MSL-8MISO NiTi Superelastic Archwire MSU-10MISO NiTi Superelastic Archwire MSU-12MISO NiTi Superelastic Archwire MSU-14MISO NiTi Superelastic Archwire MSU-16MISO NiTi Superelastic Archwire MSU-1616MISO NiTi Superelastic Archwire MSU-1622MISO NiTi Superelastic Archwire MSU-1725MISO NiTi Superelastic Archwire MSU-18MISO NiTi Superelastic Archwire MSU-1825MISO NiTi Superelastic Archwire MSU-1925MISO NiTi Superelastic Archwire MSU-20MISO NiTi Superelastic Archwire MSU-8MISO NiTi Thermal Archwire MTL-14MISO NiTi Thermal Archwire MTL-16MISO NiTi Thermal Archwire MTL-1616MISO NiTi Thermal Archwire MTL-1622MISO NiTi Thermal Archwire MTL-1725MISO NiTi Thermal Archwire MTL-18MISO NiTi Thermal Archwire MTL-1825MISO NiTi Thermal Archwire MTL-1925MISO NiTi Thermal Archwire MTL-20MISO NiTi Thermal Archwire MTL-2125MISO NiTi Thermal Archwire MTU-14MISO NiTi Thermal Archwire MTU-16MISO NiTi Thermal Archwire MTU-1616MISO NiTi Thermal Archwire MTU-1622MISO NiTi Thermal Archwire MTU-1725MISO NiTi Thermal Archwire MTU-18MISO NiTi Thermal Archwire MTU-1825MISO NiTi Thermal Archwire MTU-1925MISO NiTi Thermal Archwire MTU-20MISO NiTi Thermal Archwire MTU-2125MISO Spooled Ligature Wire MSLW-10MISO Spooled Ligature Wire MSLW-8MISO Spooled Ligature Wire MSLW-9MISO Stainless Steel Archwire MSSL-14MISO Stainless Steel Archwire MSSL-16MISO Stainless Steel Archwire MSSL-1622MISO Stainless Steel Archwire MSSL-1725MISO Stainless Steel Archwire MSSL-18MISO Stainless Steel Archwire MSSL-1825MISO Stainless Steel Archwire MSSL-1925MISO Stainless Steel Archwire MSSL-20MISO Stainless Steel Archwire MSSL-2125MISO Stainless Steel Archwire MSSL-21528MISO Stainless Steel Archwire MSSU-14MISO Stainless Steel Archwire MSSU-16MISO Stainless Steel Archwire MSSU-1622MISO Stainless Steel Archwire MSSU-1725MISO Stainless Steel Archwire MSSU-18MISO Stainless Steel Archwire MSSU-1825MISO Stainless Steel Archwire MSSU-1925MISO Stainless Steel Archwire MSSU-20MISO Stainless Steel Archwire MSSU-2125MISO Stainless Steel Archwire MSSU-21528MISO Twist Ligature Ties MTLT-10MISO Twist Ligature Ties MTLT-9MISO Wire For Lab MFL-100MISO Wire For Lab MFL-100PMISO Wire For Lab MFL-120MISO Wire For Lab MFL-120PMISO Wire For Lab MFL-35MISO Wire For Lab MFL-40MISO Wire For Lab MFL-45MISO Wire For Lab MFL-50MISO Wire For Lab MFL-60MISO Wire For Lab MFL-60PMISO Wire For Lab MFL-70MISO Wire For Lab MFL-70PMISO Wire For Lab MFL-80MISO Wire For Lab MFL-80PMISO Wire For Lab MFL-90MISO Wire For Lab MFL-90P | 2017 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | MISO Coil Spring Stainless Steel Closed Colil Spring MSCS1030MISO Coil Spring Stainless Steel Open Coil Spring MSOS1030MISO NiTi Closed Coil Spring Heavy MCS15-13HMISO NiTi Closed Coil Spring Heavy MCS15-8HMISO NiTi Closed Coil Spring Heavy MCS20-13HMISO NiTi Closed Coil Spring Heavy MCS20-8HMISO NiTi Closed Coil Spring Heavy MCS25-13HMISO NiTi Closed Coil Spring Heavy MCS25-8HMISO NiTi Closed Coil Spring Light MCS15-13LMISO NiTi Closed Coil Spring Light MCS15-8L 17 moreMISO NiTi Closed Coil Spring Light MCS20-13LMISO NiTi Closed Coil Spring Light MCS20-8LMISO NiTi Closed Coil Spring Light MCS25-13LMISO NiTi Closed Coil Spring Light MCS25-8LMISO NiTi Closed Coil Spring Medium MCS15-13MMISO NiTi Closed Coil Spring Medium MCS15-8MMISO NiTi Closed Coil Spring Medium MCS20-13MMISO NiTi Closed Coil Spring Medium MCS20-8MMISO NiTi Closed Coil Spring Medium MCS25-13MMISO NiTi Closed Coil Spring Medium MCS25-8MMISO NiTi Closed Coil Spring Ultra Light MCS15-13UMISO NiTi Closed Coil Spring Ultra Light MCS15-8UMISO NiTi Closed Coil Spring Ultra Light MCS20-13UMISO NiTi Closed Coil Spring Ultra Light MCS20-8UMISO NiTi Closed Coil Spring Ultra Light MCS25-13UMISO NiTi Closed Coil Spring Ultra Light MCS25-8UMISO NiTi Open Coil Spring MOS1030 | 2017 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | — | 2011 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Cross-MCross-MDCross-MHCross-MW | 2009 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Maker | — | 2011 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | MISO DEBONDING PLIER HT-001 | 2011 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | — | 2011 |
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 HT Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 25 Jan 2011 | K102561 | ORTHODONTIC CERAMIC BRACKET | NJM Orthodontic Ceramic Bracket |
Some of these clearances are listed with FDA today by another company: Young Innovations Inc (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HT Co., Ltd.FDA reg. 3005256634 | Yongin-si Gyeonggi, South Korea | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028610). 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.