Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011187779

FEI Number

3011187779

Entity Name

INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT

City/State/Country

Taichung City, TW

Establishment Address

No.9 Jingke Road, Nantun District, Taichung City 40852, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT (Owner Number: 10046565)

Owner / Operator Contact Address

No.9 Jingke Road, Nantun District, Taichung City, TW-TXG 40852, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122804

PMA Number

N/A

All Registered 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 Anatase spine navigation instrument WatchTower spine navigation instrument 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 SET SCREW #10-32 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 FEM AUG ATT SCR #10-32 UNF2A SET SCREW #10-32 Healix Compression Screw System STALIF MIDLINE WatchTower Spine Navigation System 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 FLEX SUPPORT SCREW MIDLINE II TI DIAMONDBACK SPINAL SYSTEM TIB WEDGE ATTACHING SCREW Anatase Spine Surgery Navigation System WatchTower Spine Navigation 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-02-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-09-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-10-29
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-09-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-08-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-08-01
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-07-14
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2021-10-19
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2014-04-08
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-09-13
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2016-09-13
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2022-03-14
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2022-03-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-02-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-12-25
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-08-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-08-07
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-04-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-08-07
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2016-09-13
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-08-08
OJH	Orthopedic Tray	General, Plastic Surgery	Class 1	878.4800	2025-07-14
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2014-04-08
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2025-08-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2014-04-08
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-09-13
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-08-25
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-09-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-12-25
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-12-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-07-14
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2016-09-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-11-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-04-08
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-07-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-02-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-03-14
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2016-03-23
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-03-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-02-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-02-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-02-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-11-06
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-09-13
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-08-01
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-08-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-08-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-09-13
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-07-14
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-09-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-02-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-12-25
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-12-04
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

Travis Hsu Business: Qualtech Consulting LLC Email: travis@qualtechs.com Phone: (626) 3455899

Related Public Records

Same Entity

INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011187779. Last updated year: 2026. Please use registration number 3011187779 when referencing this establishment in official correspondence.