FDA Registration Active 🇰🇷 South Korea

DENTOS, INCORPORATED

Reg #: 3006034256 · FEI: 3006034256 · Expires 2026
Products
12
Proprietary Names
923
Establishment Types
1
Classifications
12

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Registration Details

Registration Name
DENTOS, INCORPORATED
Registration Number
3006034256
FEI Number
3006034256
Status
Active
Expiry Year
2026
Initial Importer
No
Address
41, Seongseo-ro 68-gil, Dalseo-gu
City
DAEGU
Country
KR

Regulatory Submissions

510(k) Number
K060126

Owner / Operator

Firm Name
DENTOS, INCORPORATED
Operator Number
9081942
Address
41, Seongseo-ro 68-gil, Dalseo-gu
City
Daegu
State
KR-NOTA
Postal Code
42697
Country
KR

US Agent

Business Name
Carrasco
Contact Name
Mateo Carrasco
Address
1815 Barker Dr
City
Winter Park
State
FL
ZIP
32789
Country
US
Phone
407 2849480

Products

Device Name Product Code
Forceps, Dressing, Dental EFL
Clamp, Wire, Orthodontic ECN
Plier, Orthodontic JEX
Spring, Orthodontic ECO
Implant, Endosseous, Root-Form DZE
Wax, Dental, Intraoral EGD
Bit, Drill HTW
Implant, Endosseous, Orthodontic OAT
Wire, Orthodontic DZC
Band, Elastic, Orthodontic ECI
Bracket, Metal, Orthodontic EJF
Driver, Band, Orthodontic ECT

Proprietary Names

CF (Cotton Forcep) EF-L (Extracting Forcep-L) EF-U (Extracting Forcep-U) MCF (Mini Cotton Forcep) VCH-L-2 VCH-L-3 VCH-CS VCH-R-4 VCH-R-2 VCH-R-1 VCH-L-1 CH-L VCH-R-3 CH-S VCH-L-4 AMPLC (Angled Mini-Pin Ligature Cutter) YP (Young Plier) TRP (Tweed Rectangular arch wire bending Plier) BP (Broussard Plier) OLFP (Omega Loop Forming Plier) LUP (Lingual Utility Plier) CSH (Coil Spring Holder) LWC (Ligature Wire Cutter) Turret-S SDEC (Safety holder type of flush Distal End Cutter) TH (Tube Holder) CHP (Crimpable Hook Plier) LT (Ligature wire Tucker) NTDP (NiTi Distal wire bending Plier) BH (Bracket Holder) OH (O-ring Holder) BR (Band Remover) DEC (Distal End Cutter) UP (Utility Plier) 3PP (3 Prong plier) LWH (Ligature Wire Holder) HP (Hollow chop plier) KP (Kim's Plier) SPLC (Standard mini-Pin Ligature Cutter) HBBP (Heavy Bird Beak Plier) BBP (Bird Beak Plier) APLC (Angled Pin & Ligature Cutter) LBR (Lingual Bracket Remover) CCR (Convertible Cap Remover) Turret-L AT (Arch wire Tucker) 3PPM (Mini 3 Prong plier) HPAP(Hole Punch Aligner Plier) TDAP(Tear Drop Aligner Plier) HAP(Horizontal Aligner Plier) RAP(Retention Aligner Plier) VAP(Vertical Aligner Plier) NTDP-S(NiTi Distal wire bending Plier-S) NTDP-T(NiTi Distal wire bending Plier-T) CBRP(Ceramic Bracket Removing Plier) NT-OS NT20-13H NT20-13L NT15-13H NT20-13M NT20-8U NT15-13U NT25-13U NT20-13U NT15-13M NT15-8M NT15-13L NT15-8L NT25-8U NT25-8H NT25-13L NT15-8H NT25-13M NT20-8M NT25-13H NT15-8U NT25-8M NT20-8L NT25-8L NT20-8H ABSO ANCHOR MICROIMPLANT SF-P SF-C SF-Y SF-B SF-W SF-SET PD-25-1 PD-24-1 PD-24-1.1 PD-25-1.2 PD-31-1.1 PD-24-0.9 PD-31-1.2 PD-31-0.9 PD-24-1.2 PD-25-0.9 PD-25-1.1 PD-31-1 N-18X18-L4 NR-14X25-TL NP-19X25-TL LAB-45-12 S-20X25-L3 NTS-16X25 S-20X25-U6 NP-17X17-TU S-10-L2 ND-20X25-TL N-08-U6 NS-21X25-TL NS-16X16-OU N-14X25-L1 N-14X25-L2 S-20-U6 S-20X25-U5 NS-18-OL S-16 X 22-U6 NL-18X18-U4 NP-18-EU NP-20-TU ND-18X25-TU NP-14-EU NA-RE-L7 SR-20-EU NS-215X28-OL NA-RO-U1 S-16-L1 S-16-L2 LAB-60-500 S-16 X 25-L2 N-21X25-L2 NP-18-TL N-18X25-L2 NR-17X25-TU N-21X25-L4 NA-RS-U2 N-18X18-U5 S-17 X 17-L1 S-18X22-U5 SR-16X25-TU S-215X28-U4 S-17X22-L4 N-16X25-U6 S-14-U4 N-20-L4 NS-20-OU NB-RO-U1 ND-18X22-TU N-18-L3 LAB-60-12 N-16-L2 NP-14-TL NS-08-TL NS-18-OU N-16X25-L1 SR-21X25-EU N-14X25-L4 NP-18-TU ND-20X25-TU NB-RE-L3 NS-20X25-OU S-21X25-L2 NA-RS-L4 N-16 X 16-L3 S-10-L4 N-17 X 17-L4 ND-16X22-TU NP-08-TU N-16 X 22-U5 SR-18X25-EL NB-RE-L10 N-14X25-U5 S-215X28-L3 SR-17X25-EL NS-17X25-TU N-16X25-U4 NB-RO-U5 NP-18X18-TL LAB-50-12 S-17X25-U6 S-16 X 16-U5 S-20-L4 SL-12-TW NR-18X25-TU SR-17X22-TL NA-RO-U2 N-20-L3 ND-19X25-TU NS-16X22-TL S-20-U4 N-14-U6 SS-19X25 NP-18X22-TL S-16-U6 NTS-10 NP-10-EU NA-RE-U3 N-12-U4 SR-14X25-TU S-12-L4 NR-215X28-TU S-18-U6 NS-18X25-OL NR-14-TU S-16 X 25-U6 N-16-L3 NA-RE-U8 SR-21X25-EL NS-20-OL N-16X25-U5 NS-14-OL NR-19X25-TL SS-16X25 NA-RE-U1 NS-10-TU S-19X25-U4 S-16 X 25-U4 NTS-08 N-16 X 22-L3 SR-17X22-EU NL-18X18-L4 S-17 X 17-L3 S-17X22-L3 NA-RO-U7 N-17 X 17-U5 SR-14-TL NS-19X25-OL NR-10-TU NR-12-TL N-14-L3 LAB-120-12 N-12-U6 NR-17X22-TU NA-RE-U6 SR-16-EU NS-17X17-TU SR-18X25-EU NS-08-TU N-17X25-U5 S-18X18-L1 NS-20X25-TU SR-12-EU N-18-U5 SR-14X25-EL NA-RE-L9 N-10-U6 NS-21X25-OU S-215X28-L1 S-18X18-L4 NS-17X22-OL NB-RE-U9 N-10-U4 N-17X25-L3 SR-17X22-EL S-19X25-L2 S-16 X 16-L4 NB-RE-U3 NA-RE-L10 S-19X25-L4 S-21X25-L4 NS-215X28-OU NS-16X22-OU NB-RO-L1 S-14-L1 NA-RS-L1 NB-RO-L7 N-19X25-L3 N-16 X16-U4 SR-18X22-EL N-16-U6 ND-18X18-TL NP-21X25-EU N-18-U4 SR-17X25-EU SR-14-EU S-18X25-L4 NS-08-OL N-14-L1 NTS-14 NP-17X25-TU S-215X28-L2 NS-215X28-TU NS-16X25-TL N-12-U5 S-16-U4 SR-17X22-TU NR-14-TL N-14-U4 NP-21X25-TU N-14-L4 S-18X25-L2 S-20X25-L4 NB-RO-L5 N-18X18-U6 NS-18X25-TU SS-17X22 NA-RE-L2 S-14-U6 S-18X18-L2 NA-RE-L5 SL-12-SP N-17X25-L4 S-17X22-L1 N-12-L1 ND-16X16-TL NB-RE-U4 S-10-U5 NP-12-EU NR-16-TU S-18X22-U4 NR-21X25-TU ND-18X18-TU NR-215X28-TL NR-20X25-TU NS-19X25-TU SR-19X25-TU NS-17X22-TU S-17X25-U4 N-14-U5 S-20-L1 NR-21X25-TL ND-10-TL S-14-U5 NS-14X25-TL SR-20-TU N-16 X 16-U5 SR-215X28-EL NP-20X25-TL N-17X25-U4 SR-215X28-TL N-12-L4 N-19X25-U4 LAB-80-12 SR-215X28-EU NS-20-TL NB-RO-L3 N-18X25-U4 SL-08-TW ND-21X25-TL NA-RO-U6 NP-215X28-TL NS-18X25-TL LAB-40-12 S-20-L3 NS-14X25-TU NS-16X16-TU SR-17X17-EL NTS-17X25 SR-18-TL S-17 X 17-U6 S-12-L3 NS-12-OU NTS-20 N-08-L4 NR-18-TU NR-18X18-TL NP-16X16-TL SR-16X22-EL ND-08-TU NP-14X25-EU NS-21X25-TU NR-08-TL NB-RO-L6 NP-16X25-TL S-16-L3 N-20-L1 SR-14-TU NS-16X25-OL NP-08-EU SR-16X25-TL NP-16-TU SS-18 S-19X25-L3 N-21X25-U4 S-18X22-L3 SS-20X25 ND-215X28-TL S-18-L2 S-18-U5 NB-RE-U5 S-19X25-U6 N-16-U4 SR-215X28-TU SR-19X25-TL S-20-U5 S-21X25-L3 NA-RO-U5 SR-16-TU S-18X18-U4 SR-21X25-TL NR-16X25-TU SR-10-TU N-17X25-L2 S-215X28-L4 N-18X25-L1 S-16-U5 N-18-U6 LAB-100-12 NB-RS-L1 NP-18X18-TU ND-17X25-TU NL-17X17-L4 S-12-L2 S-215X28-U6 S-16 X 22-L3 SR-12-TL NP-215X28-TU N-19X25-L1 N-18X25-U5 N-18X25-U6 N-16 X 22-L2 ND-14X25-TL LAB-90-12 NTS-16X16 N-10-L4 S-18-L1 N-20-L2 S-18X22-L4 N-10-L2 N-17 X 17-L3 ND-14-TL SR-20X25-TU S-17 X 17-L2 S-17X25-L1 S-18X18-U5 NS-17X17-OU N-17X25-L1 ND-18-TU SR-19X25-EU S-19X25-U5 NP-19X25-TU NB-RE-U2 NA-RO-L4 SS-14X25 NB-RE-L2 NB-RE-L6 N-16 X 16-L1 NS-18X18-OU ND-215X28-TU NP-16X22-EU S-12-L1 NA-RS-L3 NS-16X22-TU S-18X25-L1 S-17X25-L3 N-10-L1 ND-17X22-TU NS-18-TL S-20X25-L1 NS-17X22-TL NB-RO-U4 S-16 X 25-L4 N-16 X 22-U4 NA-RE-U9 N-14X25-L3 ND-17X22-TL N-16 X 16-L4 ND-18X22-TL LAB-35-500 NP-16X16-TU S-18X25-L3 N-18X18-L2 ND-17X17-TL N-08-L2 NP-10-TL NS-08-OU NR-16X16-TU NB-RO-U2 NP-16X22-TL S-17X25-U5 S-16 X 16-U4 NTS-16 NS-18X18-TU S-16 X 16-L2 NR-08-TU NS-14-OU NP-17X17-TL NA-RE-U2 SS-17X17 S-16 X 22-U4 S-215X28-U5 NS-19X25-TL NS-17X25-TL N-19X25-U6 NR-18X22-TU NA-RE-L1 NA-RE-L6 NS-18X22-TL N-21X25-U6 SR-20X25-EL NB-RS-U4 NB-RS-U3 LAB-45-500 N-10-U5 NR-17X17-TU NS-17X17-TL NP-17X22-TU NR-16X22-TU NR-18X22-TL S-12-U6 SR-16X16-TU NP-18X25-TU SR-20X25-TL NS-17X17-OL ND-21X25-TU NB-RO-U6 S-18X22-U6 SS-12 NP-20X25-EU NS-12-OL S-14-L2 NS-10-OU N-16-L4 LAB-70-12 NP-12-TL NB-RE-U6 SR-18X22-TL NS-16-TU S-12-U5 S-16 X 22-L4 NA-RS-U3 N-08-L1 N-18-L4 SR-17X17-EU NS-18X22-OU S-14-L3 LAB-50-500 NP-17X17-EU SR-18X22-TU NA-RO-L2 S-18X25-U6 LAB-120-500 S-16 X 22-L2 S-16 X 25-U5 NS-16X16-OL S-10-U4 NP-08-TL SS-18X25 SS-21X25 S-18X22-L1 N-20-U5 ND-12-TU SR-19X25-EL NB-RE-L5 S-18X25-U5 NR-16-TL N-18-L2 S-10-L3 NR-17X22-TL NR-19X25-TU SS-18X22 NS-17X25-OL N-17 X 17-U6 N-21X25-L3 N-16 X 22-U6 N-12-L3 SR-12-TU NB-RS-L4 NS-20-TU S-18-L4 SR-10-EL N-10-L3 S-21X25-U6 S-17 X 17-U5 NA-RO-L5 NP-16X25-TU NS-16-TL N-16 X 16-U6 NA-RO-L1 N-12-L2 NR-10-TL ND-12-TL SR-18X22-EU N-16X25-L2 N-19X25-U5 N-20-U4 ND-16-TL ND-17X17-TU NR-14X25-TU NS-16X25-TU SS-20 N-08-L3 NR-16X22-TL NA-RS-U1 NA-RS-L2 S-21X25-L1 SR-16X16-TL N-16-L1 NP-18X22-TU NP-18X22-EU SR-12-EL NB-RE-U7 NA-RE-U7 ND-20-TU SS-16 SL-10-TW N-20-U6 NB-RE-L4 NTS-17X17 NP-215X28-EU SS-17X25 N-16-U5 N-08-U4 ND-16X22-TL N-08-U5 NB-RO-U3 S-16-L4 NB-RO-L2 NP-18X18-EU NA-RE-U5 NS-18X22-TU NA-RE-U4 NB-RE-L9 ND-08-TL NP-18X25-EU NB-RE-L8 NB-RE-U1 LAB-90-500 NS-18-TU N-17 X17-U4 NR-20X25-TL NTS-14X25 NS-18X18-OL SS-215X28 SR-14-EL SR-20X25-EU NP-17X25-TL ND-18X25-TL SR-18-TU SR-16X22-TL NB-RS-U1 NP-10-TU S-16 X 16-L1 NR-18-TL NA-RO-L6 SR-18-EU NA-RE-L4 LAB-80-500 NP-16-TL SR-17X17-TL NR-16X16-TL SL-09-TW NP-12-TU NA-RE-U10 SL-08-SP SR-16-TL S-16 X 22-L1 SR-21X25-TU NS-18X25-OU S-16 X 16-U6 NS-20X25-TL N-18X18-U4 N-14X25-U6 NS-19X25-OU N-17 X 17-L1 S-21X25-U4 S-21X25-U5 NS-14-TL S-18X22-L2 S-17X22-U4 ND-19X25-TL SR-16X25-EL S-17 X 17-L4 NA-RE-L8 NS-16X22-OL N-16 X 22-L4 NS-18X22-OL SS-10 S-16 X 25-L1 NTS-16X22 NP-17X22-EU LAB-100-500 NB-RE-L7 NA-RO-U3 SR-20-TL SS-16X22 S-14-L4 S-10-U6 ND-10-TU SS-16X16 NR-17X25-TL SR-16-EL S-18X25-U4 NP-20X25-TU S-16 X 22-U5 S-20X25-U4 N-16X25-L4 S-17X22-U5 NP-16X22-TU NS-16X25-OU NS-17X22-OU NP-14X25-TL NA-RO-L3 SR-16X16-EL S-19X25-L1 N-19X25-L4 ND-20-TL LAB-35-12 NS-12-TL NB-RO-U7 NP-20-TL NL-17X17-U4 NS-16X16-TL NTS-18X25 S-18-L3 N-16 X 16-L2 NP-16X16-EU NA-RO-U4 NB-RE-U8 ND-14-TU N-21X25-L1 NS-16-OL S-17X22-L2 NS-20X25-OL NA-RS-U4 N-14X25-U4 SR-10-TL N-16X25-L3 N-18X25-L3 N-16 X 22-L1 SR-18X25-TL NS-18X18-TL NS-10-TL NR-18X18-TU ND-16X16-TU N-19X25-L2 NB-RS-L3 NA-RE-L3 S-16 X 25-L3 S-17X25-L2 NP-19X25-EU SR-14X25-TL NB-RS-L2 NA-RO-L7 NP-14-TU N-18-L1 NTS-18X18 LAB-40-500 ND-18-TL SR-10-EU SR-17X17-TU N-18X18-L3 NB-RE-U10 NP-21X25-TL NP-16-EU ND-16-TU NS-14-TU NP-17X22-TL SR-17X25-TU NS-14X25-OL NP-17X25-EU S-18X18-L3 NP-14X25-TU SR-16X22-TU NTS-12 S-20X25-L2 NTS-21X25 N-17X25-U6 N-18X18-L1 N-18X25-L4 SR-18X25-TU N-21X25-U5 S-10-L1 ND-16X25-TL S-18X18-U6 NR-18X25-TL NS-17X25-OU SR-20-EL NR-20-TL SR-18-EL NS-12-TU SR-16X22-EU NS-14X25-OU NR-12-TU S-20-L2 N-14-L2 S-17X25-L4 ND-17X25-TL NP-20-EU SS-14 NR-16X25-TL NTS-19X25 NS-16-OU SL-10-SP NS-215X28-TL NP-16X25-EU SL-09-SP ND-16X25-TU S-16 X 16-L3 S-17 X 17-U4 S-18-U4 N-17 X 17-L2 NB-RS-U2 S-12-U4 NR-20-TU NTS-18 SR-16X25-EU SR-16X16-EU NB-RO-L4 S-17X22-U6 NS-10-OL ND-14X25-TU NB-RE-L1 SR-14X25-EU SR-17X25-TL NP-18X25-TL NR-17X17-TL NS-21X25-OL LAB-70-500 ST-055 W5-G M4-G W5-C M4-C W4-C M5-G W4-G N5-G M5-C N4-C N4-G ST-045 N5-C AA-18-U45 AA-22-33H AA-18-27H AA-18-36H AA-22-36H AA-22-3T AA-18-33H AA-18-12 AA-18-47H AA-22-77 AA-18-3L AA-22-22 AA-22-3L AA-22-11 AA-22-16H AA-18-46HH AA-18-77H AA-18-11 AA-18-6U AA-22-3U AA-22-37H AA-18-43H AA-18-66H AA-22-66H AA-22-36HH AA-22-23H AA-22-7L AA-22-7U AA-22-47H AA-22-6U AA-22-12 AA-22-55 AA-18-17H AA-18-37H AA-18-13H AA-22-27H AA-18-66 AA-18-23H AA-18-5L AA-22-77H AA-22-21 AA-18-16H AA-22-26H AA-18-7L AA-18-22 AA-18-L12 AA-18-21 AA-22-13H AA-18-36HH AA-22-46HH AA-18-6L AA-18-5U AA-18-3U AA-18-345 AA-22-17H AA-22-43H AA-18-3T AA-22-46H AA-18-7U AA-18-445 AA-22-L12 AA-18-46H AA-22-5L AA-18-7LH AA-22-7LH AA-22-6LH AA-22-66 AA-22-6L AA-22-345 AA-18-6LH AA-22-5U AA-22-445 AA-18-55 AA-18-26H AA-18-77 ED36-S SHD-L HCD ED26-L NLHD ED36-L ED19-L ED26-S ED17-S ST-S DT-L ST-L SHD-S ED19-S LHD-B ED17-L DT-S NLHD-S NLHD-S+ST-S NLHD+ST-L LHD-B+DT-L LHD-B+DT-S NLHD-S+ST-L NLHD+ST-S

Establishment Types

Manufacture Medical Device