FDA Registration Active 🇺🇸 United States

SONTEC INSTRUMENTS, INC.

Reg #: 1720747 · FEI: 1720747 · Expires 2026
Products
210
Proprietary Names
110
Establishment Types
1
Classifications
210

Registration Details

Registration Name
SONTEC INSTRUMENTS, INC.
Registration Number
1720747
FEI Number
1720747
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
7248 SOUTH TUCSON WAY
City
CENTENNIAL
State
CO
ZIP
80112
Country
US

Regulatory Submissions

510(k) Number
K972901

Owner / Operator

Firm Name
SONTEC INSTRUMENTS, INC.
Operator Number
1720747
Address
7248 SOUTH TUCSON WAY, --
City
Centennial
State
CO
Postal Code
80112
Country
US
Correspondent
Jill - Thacker

Products

Device Name Product Code
Goniometer, Nonpowered KQW
Knife, Surgical EMF
Dilator, Tracheal KCG
Chisel, Surgical, Manual FZO
Sound, Urethral, Metal Or Plastic FBX
Clamp HXD
Instruments, Surgical, Cardiovascular DWS
Electrosurgical, Cutting & Coagulation & Accessories GEI
Spoon, Ophthalmic HNB
Syringe, Ent KCP
Impactor HWA
Forceps, Rongeur, Surgical EMH
Instrument, Ligature Passing And Knot Tying HCF
Osteotome, Manual GFI
Punch, Ent KTF
Gouge, Surgical, General & Plastic Surgery GDH
Caliper KTZ
Scaler, Periodontic EMN
Trephine, Manual, Ophthalmic HRH
Staple, Removable (Skin) GDT
Instrument, Cutting, Orthopedic HTZ
Extractor HWB
Punch, Surgical LRY
Accessories, Cleaning Brushes, For Endoscope MNL
Orthopedic Manual Surgical Instrument LXH
Stripper, Vein, Reusable GAI
Scissors, Nasal KBD
Awl HWJ
Trephine HWK
Hook, Surgical, General & Plastic Surgery GDG
Excavator, Dental, Operative EKC
Burr, Corneal, Battery Powered, Rust Ring Removal OHW
Collagen Corneal Shield MOE
Forceps, General & Plastic Surgery GEN
Instruments, Dental Hand DZN
Scissors, Ophthalmic HNF
Stethoscope, Manual LDE
Tray, Surgical, Instrument FSM
Dilator, Lachrymal HNW
Instrument, Microsurgical GZX
Scissors, General, Surgical LRW
Scissors, Surgical Tissue, Dental EGN
Saw, Manual And Accessories GDR
Clamp, Non-Electrical FFN
Instrument, Bending Or Contouring HXP
Forceps, Ophthalmic HNR
Probe HXB
Trocar, Ent KTE
Clamp, Vascular DXC
Unit, Cryosurgical, Accessories GEH
Speculum, Rectal FFQ
Rasp, Surgical, General & Plastic Surgery GAC
Twister, Wire HXS
Mallet, Surgical, General & Plastic Surgery GFJ
Cannula, Ophthalmic HMX
Mallet HXL
Depressor, Tongue, Non-Surgical FMA
Rongeur HTX
Burr, Corneal, Battery-Powered HOG
Instrument, Manual, Surgical, General Use MDM
Label Or Tag, Sterile LYV
Hook, Bone KIK
Handle, Scalpel GDZ
Hammer, Surgical FZY
Device, Locking, For Intestinal Clamp FFR
Pinwheel GWY
Holder, Needle; Orthopedic HXK
Clamp, Muscle, Ophthalmic HOB
Tube, Ear Suction JZF
File, Periodontic EMR
Forceps, Ent KAE
Speculum, Vaginal, Metal HDF
Probe And Director, Gastro-Urology FGM
Transilluminator, Fiber Optic MQW
Knife, Ear JYO
Pin, Fixation, Threaded JDW
Pin, Fixation, Smooth HTY
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Screwdriver HXX
Saw, Nasal KBC
Blood Pressure Cuff DXQ
Dilator, Cervical, Fixed Size HDQ
Curette, Nasal KAP
Punch, Corneo-Scleral HNJ
Ophthalmoscope, Ac-Powered HLI
Ophthalmoscope, Battery-Powered HLJ
Laryngoscope, Rigid CCW
Dilator, Vessel, Surgical DWP
Dilator, Urethral KOE
Curette, Ear JYG
Lens, Condensing, Diagnostic HJL
Blower, Powder, Ent KCL
Osteotome HWM
Elevator HTE
Retractor, Ophthalmic HNI
Probe, Periodontic EIX
Handpiece (Brace), Drill HBD
Pliers, Surgical HTC
Snare, Non-Electrical FGX
Forceps, Biopsy, Gynecological HFB
File, Bone, Surgical EMI
Tap, Bone HWX
Spud, Ophthalmic HNA
Knife, Orthopedic HTS
Mirror, General & Plastic Surgery FTX
Punch, Adenoid KBS
Rasp HTR
Curette, Surgical, Dental EMK
Cutter, Wire HXZ
Brush, Biopsy, General & Plastic Surgery GEE
Curette, Adenoid KBJ
Applier, Staple, Surgical, GEF
Tourniquet, Nonpneumatic GAX
Laparoscope, General & Plastic Surgery GCJ
Retractor, Ent KAL
Restraint, Protective FMQ
Cutter, Surgical FZT
Blade, Saw, General & Plastic Surgery, Surgical GFA
Needle, Aspiration And Injection, Reusable GDM
Scissors, Orthopedic, Surgical HRR
Guide, Drill, Ligament LXI
Passer, Wire, Orthopedic HXI
Chisel, Osteotome, Surgical EMM
Carver, Dental Amalgam, Operative EKH
Pick, Microsurgical Ear JYT
Otoscope ERA
Forceps, Tooth Extractor, Surgical EMG
Dissector, Surgical, General & Plastic Surgery GDI
Curette, Uterine HCY
Hook, Gastro-Urology FHB
Loupe, Diagnostic/Surgical FSP
Mirror, Ent KAI
Forceps, Biopsy, Non-Electric FCL
Ligator, Hemorrhoidal FHN
Scissors, Wire Cutting, Ent, Non-Sterile NNU
Spatula, Surgical, General & Plastic Surgery GAF
Scissors, Ear JZB
Tamp HXG
Loupe, Binocular, Low Power HJH
Retractor GAD
Fork, Tuning GWX
Punch, Nasal KAY
Basin, Emesis FNY
Marker, Sclera HMQ
Unit, Examining/Treatment, Ent ETF
Sound, Uterine HHM
Retractor, Non-Self-Retaining FGN
Forceps HTD
Specula, Ophthalmic HNC
Applier, Hemostatic Clip HBT
Headlamp, Operating, Battery-Operated HPP
Ring, Ophthalmic (Flieringa) HNH
Burnisher, Operative EKJ
Retractor, All Types EIG
Electrocautery, Gynecologic (And Accessories) HGI
Spatula, Ophthalmic HND
Probe, Ent KAK
Condenser, Amalgam And Foil, Operative EKG
Elevator, Ent KAD
Cystotome HNY
Bit, Drill HTW
Hemostat, Surgical EMD
Punch, Skull GXJ
Gouge, Nasal, Ent KAQ
Burr, Orthopedic HTT
Caliper, Ophthalmic HOE
Elevator, Surgical, Dental EMJ
Dynamometer, Nonpowered HRW
Chisel, Nasal KAN
Clamp, Circumcision HFX
Knife, Ent KTG
Laparoscopic Accessories, Gynecologic NWV
Chisel (Osteotome) KDG
Laparoscope, Gynecologic (And Accessories) HET
Rasp, Ear JYY
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Instrument, Compression HWN
Hook, Microsurgical Ear JYL
Hemostat HRQ
Knife, Nasal KAS
Retractor, Fiberoptic FDG
Curette, Ophthalmic HNZ
Probe, Lachrymal HNL
Ring Cutter FNS
Retractor, Vaginal HDL
Speculum, Non-Illuminated FXE
Clamp, Surgical, General & Plastic Surgery GDJ
Source, Carrier, Fiberoptic Light EQH
Tray, Surgical LRP
Driver, Surgical, Pin GFC
Cannula, Surgical, General & Plastic Surgery GEA
Speculum, Ent EPY
Hook, Ophthalmic HNQ
Instrument, Ent Manual Surgical LRC
Tape, Measuring, Rulers And Calipers FTY
Elevator, Surgical, General & Plastic Surgery GEG
Snare, Nasal KBE
Scoop FHL
Gauge, Depth HTJ
Curette HTF
Bone Mill LYS
Holder, Needle, Gastroenterologic FHQ
Introducer, Sphere HNP
Depressor, Orbital HNX
Rongeur, Nasal KBB
Retractor, Self-Retaining FFO
Stabilizer, Heart MWS
Saw HSO
Rasp, Nasal KBA
Catheter And Tip, Suction JOL

Proprietary Names

KQW - Goniometer, nonpowered MULTIPLE Multiple URETHRAL METAL OR PLASTIC AB Bipolar Cable/Cord KCP - SYRINGE, ENT HWA - IMPACTOR CALIPER STAPLE, REMOVABLE (SKIN) EXTRACTOR ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE TREPINE EXCAVATOR, DENTAL, OPERATIVE Burr, corneal, battery powered, rust ring removal Collagen corneal shield STETHOSCOPE, MANUAL SCISSORS, SURGICAL TISSUE, DENTAL CLAMP, NON-ELECTRICAL multiple TROCAR, ENT CLAMP, VASCULAR UNIT, CRYOSURGICAL, ACCESSORIES Electrosurgical, cutting & coagulation & accessories Cannula, Ophthalmic MALLET RONGEUR Burr, corneal, battery-powered LABEL OR TAG, STERILE HANDLE, SCALPEL SURGICAL HAMMER PINWHEEL Clamp, muscle, ophthalmic FILE, PERIODONTIC GASTRO-UROLOGY PROBE AND DIRECTOR Transilluminator, fiber optic Clamp, Vascular PIN, FIXATION, SMOOTH Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) SAW, NASAL blood pressure cuff Punch, corneo-scleral Ophthalmoscope, ac-powered Ophthalmoscope, battery-powered LARYNGOSCOPE, RIGID Dilator, urethral Lens, condensing, diagnostic KCL - BLOWER, POWDER, ENT OSTEOTOME PROBE, PERIODONTIC HBD - HANDPIECE (BRACE), DRILL ADENOID PUNCH RASP BIOPSY ,GENERAL BRUSH APPLIER, STAPLE, SURGICAL, Laparoscope, general& plastic surgery ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Restraint, protective GENERAL & PLASTIC SURGERY SAW ASPIRAITON AND INJECTION REUSABLE Guide, drill, ligament OTOSCOPE CURETTE, UTERINE ENT MIRROR Tamp LOUPE BINOCULAR LOW POWER MUTLIPLE GWX - FORK, TUNING UNIT, EXAMINING/TREATMENT, ENT SOUND, UTERINE Headlamp, operating, battery-operated RING, OPHTHALMIC (FLIERINGA) ALL TYPES OF RETRACTORS ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) OPTHALMIC SPATULA ENT ELEVATOR Cystotome NASAL GOUGE (ENT PANEL) CHISEL, NASAL Circumcision Clamp KNIFE, ENT GENERAL AND PLASTIC SU Laparoscope, Gynecologic(and accessories) Laparoscope, general & plastic surgery RASP, EAR INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWN - INSTRUMENT, COMPRESSION KAS - KNIFE, NASAL RETRACTOR, FIBEROPTIC Curette, ophthalmic RING CUTTER HDL - RETRACTOR, VAGINAL FXE - SPECULUM, NON-ILLUMINATED EQH - SOURCE, CARRIER, FIBEROPTIC LIGHT SURGICAL TRAY PIN GEA - CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY ENT SPECULUM NASAL SNARE Scoop CURETTE Depressor, orbital Nasal Rongeur MWS - stabilizer,heart

Establishment Types

Repack or Relabel Medical Device