Manufacturer registered with FDA
Dentos, Inc.
Daegu, South Korea. Lists 10 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 10
- Brands and models
- 908
- 510(k) clearances
- 22006–2019
- Markets registered in
- 636 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 6 markets
Where regulators' registries name Dentos, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: South KoreaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Dentos, Inc. | 2 clearances | 2006–2019 | Below |
| Canada | Health Canada | Registration holder | DENTOS INC. | 19 | 2007–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENTOS INC. | 6 | 2004–2021 | Pure Global AI |
| China | NMPA | Registration holder | 德安科司股份有限公司Dentos Inc.德安科司股份有限公司 Dentos Inc. | 5 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Dentos Inc. | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Dentos Inc | 2 | — | 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 Dentos, Inc. 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 | LAB-100-12LAB-100-500LAB-120-12LAB-120-500LAB-35-12LAB-35-500LAB-40-12LAB-40-500LAB-45-12LAB-45-500 701 moreLAB-50-12LAB-50-500LAB-60-12LAB-60-500LAB-70-12LAB-70-500LAB-80-12LAB-80-500LAB-90-12LAB-90-500N-08-L1N-08-L2N-08-L3N-08-L4N-08-U4N-08-U5N-08-U6N-10-L1N-10-L2N-10-L3N-10-L4N-10-U4N-10-U5N-10-U6N-12-L1N-12-L2N-12-L3N-12-L4N-12-U4N-12-U5N-12-U6N-14-L1N-14-L2N-14-L3N-14-L4N-14-U4N-14-U5N-14-U6N-14X25-L1N-14X25-L2N-14X25-L3N-14X25-L4N-14X25-U4N-14X25-U5N-14X25-U6N-16 X 16-L1N-16 X 16-L2N-16 X 16-L3N-16 X 16-L4N-16 X 16-U5N-16 X 16-U6N-16 X 22-L1N-16 X 22-L2N-16 X 22-L3N-16 X 22-L4N-16 X 22-U4N-16 X 22-U5N-16 X 22-U6N-16 X16-U4N-16-L1N-16-L2N-16-L3N-16-L4N-16-U4N-16-U5N-16-U6N-16X25-L1N-16X25-L2N-16X25-L3N-16X25-L4N-16X25-U4N-16X25-U5N-16X25-U6N-17 X 17-L1N-17 X 17-L2N-17 X 17-L3N-17 X 17-L4N-17 X 17-U5N-17 X 17-U6N-17 X17-U4N-17X25-L1N-17X25-L2N-17X25-L3N-17X25-L4N-17X25-U4N-17X25-U5N-17X25-U6N-18-L1N-18-L2N-18-L3N-18-L4N-18-U4N-18-U5N-18-U6N-18X18-L1N-18X18-L2N-18X18-L3N-18X18-L4N-18X18-U4N-18X18-U5N-18X18-U6N-18X25-L1N-18X25-L2N-18X25-L3N-18X25-L4N-18X25-U4N-18X25-U5N-18X25-U6N-19X25-L1N-19X25-L2N-19X25-L3N-19X25-L4N-19X25-U4N-19X25-U5N-19X25-U6N-20-L1N-20-L2N-20-L3N-20-L4N-20-U4N-20-U5N-20-U6N-21X25-L1N-21X25-L2N-21X25-L3N-21X25-L4N-21X25-U4N-21X25-U5N-21X25-U6NA-RE-L1NA-RE-L10NA-RE-L2NA-RE-L3NA-RE-L4NA-RE-L5NA-RE-L6NA-RE-L7NA-RE-L8NA-RE-L9NA-RE-U1 | 2010 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | ABSO ANCHOR MICROIMPLANT | 2006 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | M4-CM4-GM5-CM5-GN4-CN4-GN5-CN5-GST-045ST-055 4 moreW4-CW4-GW5-CW5-G | 2010 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | CH-LCH-SVCH-CSVCH-L-1VCH-L-2VCH-L-3VCH-L-4VCH-R-1VCH-R-2VCH-R-3 1 moreVCH-R-4 | 2010 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | NT-OSNT15-13HNT15-13LNT15-13MNT15-13UNT15-8HNT15-8LNT15-8MNT15-8UNT20-13H 15 moreNT20-13LNT20-13MNT20-13UNT20-8HNT20-8LNT20-8MNT20-8UNT25-13HNT25-13LNT25-13MNT25-13UNT25-8HNT25-8LNT25-8MNT25-8U | 2010 |
| Orthodontic Band DriverECT · Class 1 | Dental hand instruments | Maker | DT-LDT-SED17-LED17-SED19-LED19-SED26-LED26-SED36-LED36-S 15 moreHCDLHD-BLHD-B+DT-LLHD-B+DT-SNHCDNLHDNLHD-SNLHD-S+ST-LNLHD-S+ST-SNLHD+ST-LNLHD+ST-SSHD-LSHD-SST-LST-S | 2010 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | SF-BSF-CSF-PSF-SETSF-WSF-Y | 2015 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | AA-18-11AA-18-12AA-18-13HAA-18-16HAA-18-17HAA-18-21AA-18-22AA-18-23HAA-18-26HAA-18-27H 65 moreAA-18-33HAA-18-345AA-18-36HAA-18-36HHAA-18-37HAA-18-3LAA-18-3TAA-18-3UAA-18-43HAA-18-445AA-18-46HAA-18-46HHAA-18-47HAA-18-55AA-18-5LAA-18-5UAA-18-66AA-18-66HAA-18-6LAA-18-6LHAA-18-6UAA-18-77AA-18-77HAA-18-7LAA-18-7LHAA-18-7UAA-18-L12AA-18-U45AA-22-11AA-22-12AA-22-13HAA-22-16HAA-22-17HAA-22-21AA-22-22AA-22-23HAA-22-26HAA-22-27HAA-22-33HAA-22-345AA-22-36HAA-22-36HHAA-22-37HAA-22-3LAA-22-3TAA-22-3UAA-22-43HAA-22-445AA-22-46HAA-22-46HHAA-22-47HAA-22-55AA-22-5LAA-22-5UAA-22-66AA-22-66HAA-22-6LAA-22-6LHAA-22-6UAA-22-77AA-22-77HAA-22-7LAA-22-7LHAA-22-7UAA-22-L12 | 2013 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | AMPLC (Angled Mini-Pin Ligature Cutter)APLC (Angled Pin & Ligature Cutter)AT (Arch wire Tucker)BBP (Bird Beak Plier)BH (Bracket Holder)BP (Broussard Plier)BR (Band Remover)CBRP(Ceramic Bracket Removing Plier)CCR (Convertible Cap Remover)CHP (Crimpable Hook Plier) 30 moreCSH (Coil Spring Holder)DEC (Distal End Cutter)HAP(Horizontal Aligner Plier)HBBP (Heavy Bird Beak Plier)HP (Hollow chop plier)HPAP(Hole Punch Aligner Plier)KP (Kim's Plier)LBR (Lingual Bracket Remover)LT (Ligature wire Tucker)LUP (Lingual Utility Plier)LWC (Ligature Wire Cutter)LWH (Ligature Wire Holder)NTDP (NiTi Distal wire bending Plier)NTDP-S(NiTi Distal wire bending Plier-S)NTDP-T(NiTi Distal wire bending Plier-T)OH (O-ring Holder)OLFP (Omega Loop Forming Plier)RAP(Retention Aligner Plier)SDEC (Safety holder type of flush Distal End Cutter)SPLC (Standard mini-Pin Ligature Cutter)TDAP(Tear Drop Aligner Plier)TH (Tube Holder)TRP (Tweed Rectangular arch wire bending Plier)Turret-LTurret-SUP (Utility Plier)VAP(Vertical Aligner Plier)YP (Young Plier)3PP (3 Prong plier)3PPM (Mini 3 Prong plier) | 2010 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | — | 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
| Establishment | Location | What it does |
|---|---|---|
| DENTOS, INCORPORATEDFDA reg. 3006034256 | DAEGU, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9081942). 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.