Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1720747

FEI Number

1720747

Entity Name

SONTEC INSTRUMENTS, INC.

City/State/Country

CENTENNIAL, CO, US

Establishment Address

7248 SOUTH TUCSON WAY, CENTENNIAL, CO 80112, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SONTEC INSTRUMENTS, INC. (Owner Number: 1720747)

Owner / Operator Contact Address

7248 SOUTH TUCSON WAY, --, Centennial, CO 80112, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQW	Goniometer, Nonpowered	Orthopedic	Class 1	888.1520	2018-02-02
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-10-30
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2014-05-30
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2012-10-30
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	1992-10-14
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	1992-07-20
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2012-10-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-28
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	1992-07-21
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2018-02-08
HWA	Impactor	Orthopedic	Class 1	888.4540	2018-02-02
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2012-10-30
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2014-05-30
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2014-05-30
KTF	Punch, Ent	Ear, Nose, Throat	Class 1	874.4420	2012-10-30
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-10-30
KTZ	Caliper	Orthopedic	Class 1	888.4150	2016-12-12
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	1992-07-21
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-10-30
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2018-10-25
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	1992-07-21
HWB	Extractor	Orthopedic	Class 1	888.4540	2019-05-16
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-31
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2018-09-24
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1992-07-21
GAI	Stripper, Vein, Reusable	General, Plastic Surgery	Class 1	878.4800	2014-05-30
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2010-06-02
HWJ	Awl	Orthopedic	Class 1	888.4540	1992-07-21
HWK	Trephine	Orthopedic	Class 1	888.4540	1992-10-14
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2010-06-02
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2017-12-18
OHW	Burr, Corneal, Battery Powered, Rust Ring Removal	Ophthalmic	Class 1	886.4070	2017-02-03
MOE	Collagen Corneal Shield	Ophthalmic	Class 1	886.4750	2019-03-15
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-10-30
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2013-01-02
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-06-02
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2018-03-08
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-05-30
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2014-05-30
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2012-07-19
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-06-02
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2017-12-18
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2013-01-31
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2018-12-03
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2012-10-30
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-12-28
HXB	Probe	Orthopedic	Class 1	888.4540	2013-01-02
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2018-12-03
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2019-06-12
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2018-07-26
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2010-06-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-07-31
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-31
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	1992-07-21
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-10-30
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-04-20
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	1992-10-14
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2013-01-02
HTX	Rongeur	Orthopedic	Class 1	888.4540	1992-10-14
HOG	Burr, Corneal, Battery-Powered	Ophthalmic	Class 1	886.4070	2018-10-29
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-02
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2018-08-22
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2010-06-02
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2019-02-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-07-31
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	1992-10-14
FFR	Device, Locking, For Intestinal Clamp	Gastroenterology, Urology	Class 1	876.4730	2014-05-30
GWY	Pinwheel	Neurology	Class 1	882.1750	2018-09-05
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2010-06-02
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	2020-07-22
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2010-06-02
EMR	File, Periodontic	Dental	Class 1	872.4565	2019-05-24
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2010-12-28
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2014-05-30
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	1992-10-14
MQW	Transilluminator, Fiber Optic	Ear, Nose, Throat	Class 1	874.4350	2018-03-08
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2012-10-30
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2017-04-11
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2013-01-02
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-01-02
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	1992-07-21
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2012-10-30
KBC	Saw, Nasal	Ear, Nose, Throat	Class 1	874.4420	2023-07-27
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2018-03-08
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2014-05-30
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2012-10-30
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2017-12-18
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2018-03-08
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2018-03-08
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2018-03-08
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2017-08-24
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2013-01-02
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2017-12-18
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2012-10-30
HJL	Lens, Condensing, Diagnostic	Ophthalmic	Class 1	886.1380	2018-03-08
KCL	Blower, Powder, Ent	Ear, Nose, Throat	Class 1	874.5220	2018-02-08
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	1992-10-14
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2010-06-02
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-31
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2019-05-22
HBD	Handpiece (Brace), Drill	Neurology	Class 1	882.4325	2018-02-07
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	1992-07-21
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2014-05-30
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2014-05-30
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2014-05-30
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	1992-07-21
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-10-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-07-31
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2014-05-30
FTX	Mirror, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-02
KBS	Punch, Adenoid	Ear, Nose, Throat	Class 1	874.4420	1992-10-14
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	1992-10-14
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2012-10-30
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2012-10-30
GEE	Brush, Biopsy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1992-10-14
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2013-01-31
GEF	Applier, Staple, Surgical,	General, Plastic Surgery	Class 1	878.4800	2018-10-25
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2014-05-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-03-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-12
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2014-05-30
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2021-03-08
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-31
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	1992-10-14
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	1992-10-14
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	1992-10-14
LXI	Guide, Drill, Ligament	General, Plastic Surgery	Class 1	878.4820	2017-12-18
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	1992-07-21
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2012-10-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-07-31
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2014-05-30
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2013-01-02
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2018-03-08
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2014-09-24
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-02
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2017-12-18
FHB	Hook, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2010-06-02
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2014-05-30
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	1992-10-14
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2010-12-28
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2010-06-02
NNU	Scissors, Wire Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2010-06-02
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-10-30
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2010-06-02
HXG	Tamp	Orthopedic	Class 1	888.4540	2026-06-04
HJH	Loupe, Binocular, Low Power	Ophthalmic	Class 1	886.5120	1992-10-14
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-10-30
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2018-02-08
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	2013-01-31
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	1992-07-21
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	1992-07-21
ETF	Unit, Examining/Treatment, Ent	Ear, Nose, Throat	Class 1	874.5300	2018-03-08
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2017-12-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-02-03
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2012-10-30
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2010-12-28
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-02
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	2014-05-30
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	Class 1	886.4335	2018-07-26
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2018-06-11
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2014-05-30
EIG	Retractor, All Types	Dental	Class 1	872.4565	1992-10-14
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2018-07-26
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	1992-10-14
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2013-01-02
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	2014-05-30
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	1992-10-14
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2019-05-16
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2014-05-30
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	1992-07-21
GXJ	Punch, Skull	Neurology	Class 1	882.4750	2014-05-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-07-31
KAQ	Gouge, Nasal, Ent	Ear, Nose, Throat	Class 1	874.4420	1992-10-14
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2014-05-30
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	1992-07-21

Official Correspondent

Jill Thacker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SONTEC INSTRUMENTS, INC.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1720747. Last updated year: 2026. Please use registration number 1720747 when referencing this establishment in official correspondence.