FDA Registration Active 🇹🇼 Taiwan

INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT

Reg #: 3011187779 · FEI: 3011187779 · Expires 2026
Products
26
Proprietary Names
354
Establishment Types
3
Classifications
26

Registration Details

Registration Name
INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT
Registration Number
3011187779
FEI Number
3011187779
Status
Active
Expiry Year
2026
Initial Importer
No
Address
No.9 Jingke Road, Nantun District
City
Taichung City
Country
TW

Regulatory Submissions

510(k) Number
K122804

Owner / Operator

Firm Name
INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT
Operator Number
10046565
Address
No.9 Jingke Road, Nantun District
City
Taichung City
State
TW-TXG
Postal Code
40852
Country
TW

US Agent

Business Name
Qualtech Consulting LLC
Contact Name
Travis Hsu
Address
532 Arboles St
City
Monterey Park
State
CA
ZIP
91754
Country
US
Phone
626 3455899

Products

Device Name Product Code
Implant, Endosseous, Root-Form DZE
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Screw, Fixation, Bone HWC
Plate, Fixation, Bone HRS
Orthopedic Stereotaxic Instrument OLO
Bit, Drill HTW
Drill, Dental, Intraoral DZA
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Orthosis, Spinal Pedicle Fixation MNI
Orthosis, Spondylolisthesis Spinal Fixation MNH
Abutment, Implant, Dental, Endosseous NHA
Appliance, Fixation, Spinal Intervertebral Body KWQ
Orthopedic Manual Surgical Instrument LXH
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
Orthopedic Tray OJH
Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Thoracolumbosacral Pedicle Screw System NKB
Posterior Cervical Screw System NKG
Appliance, Fixation, Spinal Interlaminal KWP
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
Accessories, Implant, Dental, Endosseous NDP
Wrench HXC

Proprietary Names

SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D EXTENSION SCREW FLEX SUPPORT SCREW Healix Compression Screw System SET SCREW #10-32 Gaudi Proximal Humerus Plate Remex Spine Surgery Navigation System II WatchTower spine navigation system Drill bit Anatase spine navigation instrument WatchTower spine navigation instrument CF 4.3 x 10 Final Implant Drill EF 4 x 15 Final Implant Drill CF 5 x 11.5 Final Implant Drill 2 13 Twist Drill 2.8-3.2 8.5-15mm Step Drill 2 10 Twist Drill CF 3.5 x 13 Final Implant Drill 2.4-2.8 7-11.5mm Step Drill CF 4.3 x 13 Final Implant Drill EF 5 x 15 Final Implant Drill 2.4-2.8 Twist Step Drill_Long CF 5 x 13 Final Implant Drill CF 3.5 x 15 Final Implant Drill 3.2-3.6 Twist Step Drill_Long CF 3.9 x 15 Final Implant Drill EF 4.5 x 13 Final Implant Drill EF 4.5 x 10 Final Implant Drill CF 4.3 x 8.5Final Implant Drill 4.2-4.6 Twist Step Drill_Long CF 5 x 8.5 Final Implant Drill 3 F3.5 Cortical Drill 3.3 Twist Drill 7-11.5mm EF 4.5 x 8.5 Final Implant Drill EF 5 x 11.5 Final Implant Drill 2 11.5 Twist Drill CF 4.3 x 11.5 Final Implant Drill 3.3 Twist Drill 8.5-15mm CF 3.5 x 8.5 Final Implant Drill 2 8.5 Twist Drill 1.5 Lance Drill Twist Drill 2 7-11.5 CF 5 x 10 Final Implant Drill CF 3.9 x 11.5 Final Implant Drill EF 5 x 8.5 Final Implant Drill CF 3.9 x 13 Final Implant Drill EF 4 x 11.5 Final Implant Drill 2 Lance Drill EF 5 x 13 Final Implant Drill 3 Twist Drill 8.5-15mm 3.8-4.2 8.5-15mm Step Drill EF 3.5 x 10 Final Implant Drill 2.3 Guide Drill EF 4.5 x 11.5 Final Implant Drill 3.3 Twist Drill_Long EF 4.5 x 15 Final Implant Drill 2.8-3.2 7-11.5mm Step Drill EF 4 x 8.5 Final Implant Drill EF 4 x 13 Final Implant Drill 3 F4.5 Cortical Drill CF 3.9 x 10 Final Implant Drill 2.4-2.8 8.5-15mm Step Drill 3.8 Twist Drill 8.5-15mm Twist Drill 2_Long 2 15 Twist Drill Twist Drill 28.5-15 4.3 Twist Drill 8.5-15mm Lindemann cut Drill 1.8 Guide Drill EF 3.5 x 13 Final Implant Drill CF 4.3 x 15 Final Implant Drill 4.3 Twist Drill_Long 3.8 Twist Drill 7-11.5mm 3 Twist Drill_Long EF 5 x 10 Final Implant Drill EF 3.5 x 8.5 Final Implant Drill CF 3.5 x 10 Final Implant Drill 4.2-4.6 8.5-15mm Step Drill 3 F5 Cortical Drill 1.8 Lance Drill 3.8-4.2 7-11.5mm Step Drill 3-3.8 Pilot Drill 2.8-3.2 Twist Step Drill_Long 3 Twist Drill 7-11.5mm EF 3.5 x 15 Final Implant Drill CF 3.9 x 8.5 Final Implant Drill CF 3.5 x 11.5 Final Implant Drill 3.2-3.6 7-11.5mm Step Drill 3 F4 Cortical Drill 2-3 Pilot Drill 4.2-4.6 7-11.5mm Step Drill CF 5 x 15 Final Implant Drill 3.2-3.6 8.5-15mm Step Drill 3.8 Twist Drill_Long EF 3.5 x 11.5 Final Implant Drill EF 4 x 10 Final Implant Drill 4.3 Twist Drill 7-11.5mm 3.6-4.2 Twist Step Drill_Long MIS TM POROUS FLEX SCREW Pedicle screw spinal system TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENT SkyWalker Total Knee System Trifore(tm) Cervical Plating System SW 183XX, Captiva Driver, Bone Pin, Slide hammer, Releaser, Guide Pin 540L Cervical Plate System TIB WEDGE ATTACHING SCREW OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM Orthopedic tray STALIF X STALIF C(R) Spinal Intervertebral Body Fixation Appliance SUPPORT SCREW LCCK YELLOW SUPPORT SCR LCCK BLU/STR BLU LCCK SUPPORT SCREW FEM AUG ATT SCR #10-32 UNF2A SUPPORT SCR LCCK GREN/STR GRN WatchTower Spine Navigation System Anatase Surgery Navigation System ATTACHING SCREW INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM Remex Spine Surgery Navigation Instrument WatchTower Spine Navigation Instrument Watchtower Navi Disposable Instrument Anatase Navi Disposable Instrument STALIF MIDLINE Anatase Spine Surgery Navigation System PARAGON IMPLANT SYSTEM Thoracolumbosacral pedicle screw system ALTOS Posterior Cervical Thoracic System TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620 INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM CASTABLE ABUTMENTS Tangis APPLIANCE, FIXATION, SPINAL, INTERVERTEBRAL BODY MIDLINE II TI DIAMONDBACK SPINAL SYSTEM MIS DROP DOWN STEM EXT 45MM MIS DROP DOWN STEM PLUG MIS DROP DOWN STEM EXT FLUSH MIS FLEX SCREW MIS DROP DOWN STEM EXT 75MM SCREW-VENT DENTAL IMPLANT SYSTEM 5MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM Spinal Intervertebral Body Fixation Orthosis STALIF TM C CapLOX II®/TowerLOX® MIS Pedicle Screw System OsteoFit Single-Use Acetabular Reamer INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT STALIF C Scan body-Insert Large parallel surgical guide SRAPU42 Screw-Retained abutment Pick-up IP4160S Implant Pick-up (HEX) 4.5-5 Implant Torque Driver (Eureka) Short 20 mm Hex Screwdriver Stainless steel IP6120S Implant Pick-up (HEX) ITS160S Implant Transfer Screw C-SYSTEM IMPLANT SURGICAL KITSTANDARD R 10 mmL 2-4 short Drill Stopper IP412VS Implant Pick-up parallel surgical guide kit 3.5-4.3 Short 19 mm Implant Driver (Cullinan) IT516HL Implant Transfer (HEX) Ball Wrench 8.5 mmL 4-5 short Drill Stopper IPU26VS Implant Pick-up SRAAPU0 Screw-Retained angled abutment Pick-up dental implant surgical kit IT412HS Implant Transfer (HEX) Long 35 mm Hex CA Driver Stainless steel IP516VS Implant Pick-up Screw-Retained Abutment Analog Short 18 mm Screw-Retained Abutment Driver Scan body-Insert Small IP116VS Implant Pick-up IT016HL Implant Transfer(HEX) IPU260S Implant Pick-up (HEX) IP4120L Implant Pick-up (HEX) 5 Parallel Pin 3.5-4 Implant Torque Driver (Eureka) IT112HS Implant Transfer (HEX) Ball Insert Tool SID-MD-L Implant Driver Digital Implant Analog Bottom Screw Intermediate 31 mm T6 Hex Screwdriver Stainless steel IPU210S Implant Pick-up (HEX) IT0180L Implant Transfer(HEX) 4 Parallel Pin ITS12HL Implant Transfer Screw SRAR00A Screw-Retained Angled abutment Analog 5 Implant Tap AZURE INTRAORAL SCAN BODY LARGE 4MM(H) Prosthetic surgical tray IT612HS Implant Transfer (HEX) IP5120S Implant Pick-up (HEX) SID-CA-L Implant Driver IPU21MS Implant Pick-up Screw IT0210L Implant Transfer(HEX) AZURE DESKTOP SCAN BODY SMALL 7MM(H) Digital Implant Analog Large Short 24 mm Slot CA Driver Drill Stopper- I8.5 (2-4)Long Drill Stopper- I15 (4-5)Long 3.5-4 Long 28 mm Implant Driver Drill Stopper- I11.5 (2-4)Long SID-MD-S Implant Driver AZURE INTRAORAL SCAN BODY SMALL 4MM(H) SCREW-RETAINED ABUTMENT BONE PROFILER PIN SMALL IT416HS Implant Transfer (HEX) Drill Stopper- I8.5 (4-5)Long Implant surgical tray premium Long 35 mm T6 Hex CA Driver Stainless steel 8.5 mmL 2-4 short Drill Stopper BAR0001 Ball Abutment Analog IP4160L Implant Pick-up (HEX) IP616VS Implant Pick-up 5 Long 28 mm Implant Driver (Culinan) Drill Stopper- I10 (2-4)Long AS DRIVER SHORT CA AZURE DESKTOP SCAN BODY LARGE 7MM(H) Intermediate 30 mm Slot Screwdriver 7 mmL 4-5 short Drill Stopper 3.5-4 Short 19 mm Implant Driver SCREW-RETAINED ABUTMENT BONE PROFILER SMALL IP6160L Implant Pick-up (HEX) LID-CA-S Implant Driver IPU22VL Implant Pick-up IP612VS Implant Pick-up SRAPU54 Screw-Retained abutment Pick-up LID-MD-S Implant Driver IT512HS Implant Transfer (HEX) ITS16HL Implant Transfer Screw 10 mmL 4-5 short Drill Stopper ITS12HS Implant Transfer Screw IT512HL Implant Transfer (HEX) AZURE DIGITAL & STONE ANALOG LARGE Angulated solution Lab Screw Small SRAR045 Screw-Retained abutment Analog IPU26MS Implant Pick-up Screw Short 24 mm Hex CA Driver Stainless steel Scan body-Lock Large IPU220L Implant Pick-up (HEX) Stopper Holder 2-4 Implant Depth Gauge 6–15 mm Titanium IP6160S Implant Pick-up (HEX) AS DRIVER SHORT MD Drill Extension IPU27ML Implant Pick-up Screw Abutment Depth Gauge 7 mmL 2-4 short Drill Stopper IP516VL Implant Pick-up ANALOG PLACEMENT TOOL Drill Stopper- I11.5 (4-5)Long AS DRIVER LONG CA Angulated solution Lab Screw Large Stopper Holder 4-5 LID-CA-L Implant Driver AZURE DIGITAL & STONE ANALOG SMALL IT016HS Implant Transfer(HEX) IT116HS Implant Transfer (HEX) ITS16HS Implant Transfer Screw Digital Implant Analog Small 5 Implant Torque Driver (Cullinan) Drill Stopper- I15 (2-4)Long 4 Implant Tap IT012HL Implant Transfer(HEX) IR0155L Implant replica Analog SRAAPUS Screw-Retained angled abutment Pick-up Screw BAPU001 Ball Abutment Pick-up Short 20 mm Slot Screwdriver SRAPU52 Screw-Retained abutment Pick-up 5 Implant Tap Cement-Retained abutment Lab Screw 4.5-5 Long 28 mm Implant Driver IR0150S Implant replica Analog Torque Wrench Scan body-Lock Small IT616HS Implant Transfer (HEX) IT616HL Implant Transfer (HEX) ITS210L Implant Transfer Screw Scan-body Lock Screw Large IP4120S Implant Pick-up (HEX) IP5160L Implant Pick-up (HEX) 3.9 Implant Tap IP512VL Implant Pick-up IPU21VS Implant Pick-up Long 30 mm Screw-Retained Abutment Driver BAOR001 Ball Abutment O-ring Screw-Retained Abutment Polishing Protector 4.5-5 Short 20 mm Implant Driver 3.5-4.3 Implant Torque Driver (Cullinan) Direction Indicator Driver Handle Stainless steel SRAT000 Screw-Retained abutment Transfer IPU22ML Implant Pick-up Screw IP612VL Implant Pick-up IP5160S Implant Pick-up (HEX) IP416VS Implant Pick-up 5 Short 20 mm Implant Driver (Culinan) IP616VL Implant Pick-up Long 35 mm Slot CA Driver Intermediate 31 mm Hex Screwdriver Stainless steel IPU27VL Implant Pick-up SCREW-RETAINED ABUTMENT BONE PROFILER LARGE IP416VL Implant Pick-up Long 43 mm Hex Screwdriver Stainless steel SRAR020 Screw-Retained abutment Analog 4.3 Implant Tap IP5120L Implant Pick-up (HEX) IP6120L Implant Pick-up (HEX) IPU270L Implant Pick-up (HEX) IT0160S Implant Transfer(HEX) IP412VL Implant Pick-up ITS180L Implant Transfer Screw Short 24 mm T6 Hex CA Driver Stainless steel IP1120S Implant Pick-up (HEX) AS DRIVER LONG MD Scan body-Lock Screw Small Screw-Retained Abutment Transfer Impression Coping Short 20 mm T6 Hex Screwdriver Stainless steel Screw-Retained Abutment Pick-up Impression Coping SRAPU44 Screw-Retained abutment Pick-up SRAPU13 Screw-Retained abutment Pick-up Screw Screw-Retained Abutment Scan Body 4mm(H) SRAPU16 Screw-Retained abutment Pick-up Screw IP112VS Implant Pick-up 3.5-4.3 Long 28 mm Implant Driver (Culinan) 4.5 Implant Tap Drill Stopper- I13 (2-4)Long ITS190S Implant Transfer Screw IP1160S Implant Pick-up (HEX) SCREW-RETAINED ABUTMENT ABUTMENT TIP DRIVER 24 mm (L) Drill Stopper- I13 (4-5)Long E-system surgical tray SCREW-RETAINED ABUTMENT ABUTMENT MANUAL DRIVER 17 mm (L) SID-CA-S Implant Driver IP512VS Implant Pick-up Screw-Retained Abutment Waxing Screw IT516HS Implant Transfer (HEX) IT612HL Implant Transfer (HEX) IT012HS Implant Transfer(HEX) 3.5 Implant Tap SCREW-RETAINED ABUTMENT ABUTMENT MANUAL DRIVER 24 mm (L) IT0190S Implant Transfer(HEX) Long 43 mm T6 Hex Screwdriver Stainless steel SCREW-RETAINED ABUTMENT BONE PROFILER PIN LARGE Drill Stopper- I10 (4-5)Long Hex Key Wrench #3, Hex Key Wrench #2, Post Wrench Superior Anterior Clavicle Plate(04112026) PREFORMANCE POSTS AND TEMPORARY CYLINDERS ADVENT IMPLANT SYSTEM

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device