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
- [email protected]
- Phone
- 626 3455899
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2025-02-07 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2016-09-13 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-10-29 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-08-01 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-07-14 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2021-10-19 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2014-04-08 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2016-09-13 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2022-03-14 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2022-03-14 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2024-12-25 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-08-07 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-04-08 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2016-09-13 |
| Orthopedic Tray | OJH | Class 1 | General, Plastic Surgery | No | 2025-07-14 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2014-04-08 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2025-08-01 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2016-09-13 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2014-04-08 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-03-14 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2016-03-23 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2016-03-23 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2022-06-28 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2025-09-12 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2016-11-23 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2025-07-14 |
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 615 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