Dental Device Guide
Add your company

Manufacturer registered with FDA

Intai Technology Corp. Implants Business Unit

Taichung City, Taiwan. Lists 4 dental device types with FDA across 1 registered establishment.

FDA owner/operator10046565Contract manufacturerManufacturer
Device types listed
4
Brands and models
299
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1Taiwan

Devices listed with FDA

What Intai Technology Corp. Implants Business Unit currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Root-Form Endosseous ImplantDZE · Class 2Dental implantsMaker
ADVENT IMPLANT SYSTEMCASTABLE ABUTMENTSINTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEMINTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEMPARAGON IMPLANT SYSTEMROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMSCREW-VENT DENTAL IMPLANT SYSTEMSPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENTSWISSPLUS 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/OP2.8DTEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG
1 more
5MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS
2024
Endosseous Dental Implant AbutmentNHA · Class 2Implant abutmentsMaker
BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTPREFORMANCE POSTS AND TEMPORARY CYLINDERSROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMTI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620
2024
Intraoral Dental DrillDZA · Class 1Surgical drills & motorsMaker
CF 3.5 x 10 Final Implant DrillCF 3.5 x 11.5 Final Implant DrillCF 3.5 x 13 Final Implant DrillCF 3.5 x 15 Final Implant DrillCF 3.5 x 8.5 Final Implant DrillCF 3.9 x 10 Final Implant DrillCF 3.9 x 11.5 Final Implant DrillCF 3.9 x 13 Final Implant DrillCF 3.9 x 15 Final Implant DrillCF 3.9 x 8.5 Final Implant Drill
77 more
CF 4.3 x 10 Final Implant DrillCF 4.3 x 11.5 Final Implant DrillCF 4.3 x 13 Final Implant DrillCF 4.3 x 15 Final Implant DrillCF 4.3 x 8.5Final Implant DrillCF 5 x 10 Final Implant DrillCF 5 x 11.5 Final Implant DrillCF 5 x 13 Final Implant DrillCF 5 x 15 Final Implant DrillCF 5 x 8.5 Final Implant DrillEF 3.5 x 10 Final Implant DrillEF 3.5 x 11.5 Final Implant DrillEF 3.5 x 13 Final Implant DrillEF 3.5 x 15 Final Implant DrillEF 3.5 x 8.5 Final Implant DrillEF 4 x 10 Final Implant DrillEF 4 x 11.5 Final Implant DrillEF 4 x 13 Final Implant DrillEF 4 x 15 Final Implant DrillEF 4 x 8.5 Final Implant DrillEF 4.5 x 10 Final Implant DrillEF 4.5 x 11.5 Final Implant DrillEF 4.5 x 13 Final Implant DrillEF 4.5 x 15 Final Implant DrillEF 4.5 x 8.5 Final Implant DrillEF 5 x 10 Final Implant DrillEF 5 x 11.5 Final Implant DrillEF 5 x 13 Final Implant DrillEF 5 x 15 Final Implant DrillEF 5 x 8.5 Final Implant DrillLindemann cut DrillTwist Drill 2 7-11.5Twist Drill 2_LongTwist Drill 28.5-151.5 Lance Drill1.8 Guide Drill1.8 Lance Drill2 10 Twist Drill2 11.5 Twist Drill2 13 Twist Drill2 15 Twist Drill2 8.5 Twist Drill2 Lance Drill2-3 Pilot Drill2.3 Guide Drill2.4-2.8 7-11.5mm Step Drill2.4-2.8 8.5-15mm Step Drill2.4-2.8 Twist Step Drill_Long2.8-3.2 7-11.5mm Step Drill2.8-3.2 8.5-15mm Step Drill2.8-3.2 Twist Step Drill_Long3 F3.5 Cortical Drill3 F4 Cortical Drill3 F4.5 Cortical Drill3 F5 Cortical Drill3 Twist Drill 7-11.5mm3 Twist Drill 8.5-15mm3 Twist Drill_Long3-3.8 Pilot Drill3.2-3.6 7-11.5mm Step Drill3.2-3.6 8.5-15mm Step Drill3.2-3.6 Twist Step Drill_Long3.3 Twist Drill 7-11.5mm3.3 Twist Drill 8.5-15mm3.3 Twist Drill_Long3.6-4.2 Twist Step Drill_Long3.8 Twist Drill 7-11.5mm3.8 Twist Drill 8.5-15mm3.8 Twist Drill_Long3.8-4.2 7-11.5mm Step Drill3.8-4.2 8.5-15mm Step Drill4.2-4.6 7-11.5mm Step Drill4.2-4.6 8.5-15mm Step Drill4.2-4.6 Twist Step Drill_Long4.3 Twist Drill 7-11.5mm4.3 Twist Drill 8.5-15mm4.3 Twist Drill_Long
2014
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
Abutment Depth GaugeANALOG PLACEMENT TOOLAngulated solution Lab Screw LargeAngulated solution Lab Screw SmallAS DRIVER LONG CAAS DRIVER LONG MDAS DRIVER SHORT CAAS DRIVER SHORT MDAZURE DESKTOP SCAN BODY LARGE 7MM(H)AZURE DESKTOP SCAN BODY SMALL 7MM(H)
187 more
AZURE DIGITAL & STONE ANALOG LARGEAZURE DIGITAL & STONE ANALOG SMALLAZURE INTRAORAL SCAN BODY LARGE 4MM(H)AZURE INTRAORAL SCAN BODY SMALL 4MM(H)Ball Insert ToolBall WrenchBAOR001 Ball Abutment O-ringBAPU001 Ball Abutment Pick-upBAR0001 Ball Abutment AnalogC-SYSTEM IMPLANT SURGICAL KITSTANDARD RCement-Retained abutment Lab Screwdental implant surgical kitDigital Implant Analog Bottom ScrewDigital Implant Analog LargeDigital Implant Analog SmallDirection IndicatorDrill ExtensionDrill Stopper- I10 (2-4)LongDrill Stopper- I10 (4-5)LongDrill Stopper- I11.5 (2-4)LongDrill Stopper- I11.5 (4-5)LongDrill Stopper- I13 (2-4)LongDrill Stopper- I13 (4-5)LongDrill Stopper- I15 (2-4)LongDrill Stopper- I15 (4-5)LongDrill Stopper- I8.5 (2-4)LongDrill Stopper- I8.5 (4-5)LongDriver Handle Stainless steelE-system surgical trayImplant Depth Gauge 6–15 mm TitaniumImplant surgical tray premiumIntermediate 30 mm Slot ScrewdriverIntermediate 31 mm Hex Screwdriver Stainless steelIntermediate 31 mm T6 Hex Screwdriver Stainless steelIP1120S Implant Pick-up (HEX)IP112VS Implant Pick-upIP1160S Implant Pick-up (HEX)IP116VS Implant Pick-upIP4120L Implant Pick-up (HEX)IP4120S Implant Pick-up (HEX)IP412VL Implant Pick-upIP412VS Implant Pick-upIP4160L Implant Pick-up (HEX)IP4160S Implant Pick-up (HEX)IP416VL Implant Pick-upIP416VS Implant Pick-upIP5120L Implant Pick-up (HEX)IP5120S Implant Pick-up (HEX)IP512VL Implant Pick-upIP512VS Implant Pick-upIP5160L Implant Pick-up (HEX)IP5160S Implant Pick-up (HEX)IP516VL Implant Pick-upIP516VS Implant Pick-upIP6120L Implant Pick-up (HEX)IP6120S Implant Pick-up (HEX)IP612VL Implant Pick-upIP612VS Implant Pick-upIP6160L Implant Pick-up (HEX)IP6160S Implant Pick-up (HEX)IP616VL Implant Pick-upIP616VS Implant Pick-upIPU210S Implant Pick-up (HEX)IPU21MS Implant Pick-up ScrewIPU21VS Implant Pick-upIPU220L Implant Pick-up (HEX)IPU22ML Implant Pick-up ScrewIPU22VL Implant Pick-upIPU260S Implant Pick-up (HEX)IPU26MS Implant Pick-up ScrewIPU26VS Implant Pick-upIPU270L Implant Pick-up (HEX)IPU27ML Implant Pick-up ScrewIPU27VL Implant Pick-upIR0150S Implant replica AnalogIR0155L Implant replica AnalogIT012HL Implant Transfer(HEX)IT012HS Implant Transfer(HEX)IT0160S Implant Transfer(HEX)IT016HL Implant Transfer(HEX)IT016HS Implant Transfer(HEX)IT0180L Implant Transfer(HEX)IT0190S Implant Transfer(HEX)IT0210L Implant Transfer(HEX)IT112HS Implant Transfer (HEX)IT116HS Implant Transfer (HEX)IT412HS Implant Transfer (HEX)IT416HS Implant Transfer (HEX)IT512HL Implant Transfer (HEX)IT512HS Implant Transfer (HEX)IT516HL Implant Transfer (HEX)IT516HS Implant Transfer (HEX)IT612HL Implant Transfer (HEX)IT612HS Implant Transfer (HEX)IT616HL Implant Transfer (HEX)IT616HS Implant Transfer (HEX)ITS12HL Implant Transfer ScrewITS12HS Implant Transfer ScrewITS160S Implant Transfer ScrewITS16HL Implant Transfer ScrewITS16HS Implant Transfer ScrewITS180L Implant Transfer ScrewITS190S Implant Transfer ScrewITS210L Implant Transfer ScrewLID-CA-L Implant DriverLID-CA-S Implant DriverLID-MD-S Implant DriverLong 30 mm Screw-Retained Abutment DriverLong 35 mm Hex CA Driver Stainless steelLong 35 mm Slot CA DriverLong 35 mm T6 Hex CA Driver Stainless steelLong 43 mm Hex Screwdriver Stainless steelLong 43 mm T6 Hex Screwdriver Stainless steelparallel surgical guideparallel surgical guide kitProsthetic surgical trayScan body-Insert LargeScan body-Insert SmallScan body-Lock LargeScan body-Lock Screw SmallScan body-Lock SmallScan-body Lock Screw LargeSCREW-RETAINED ABUTMENT ABUTMENT MANUAL DRIVER 17 mm (L)SCREW-RETAINED ABUTMENT ABUTMENT MANUAL DRIVER 24 mm (L)SCREW-RETAINED ABUTMENT ABUTMENT TIP DRIVER 24 mm (L)Screw-Retained Abutment AnalogSCREW-RETAINED ABUTMENT BONE PROFILER LARGESCREW-RETAINED ABUTMENT BONE PROFILER PIN LARGESCREW-RETAINED ABUTMENT BONE PROFILER PIN SMALLSCREW-RETAINED ABUTMENT BONE PROFILER SMALLScrew-Retained Abutment Pick-up Impression CopingScrew-Retained Abutment Polishing ProtectorScrew-Retained Abutment Scan Body 4mm(H)Screw-Retained Abutment Transfer Impression CopingScrew-Retained Abutment Waxing ScrewShort 18 mm Screw-Retained Abutment DriverShort 20 mm Hex Screwdriver Stainless steelShort 20 mm Slot ScrewdriverShort 20 mm T6 Hex Screwdriver Stainless steelShort 24 mm Hex CA Driver Stainless steel
2016

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Also lists devices cleared under other names

Intai Technology Corp. Implants Business Unit lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Intai Technology Corp. (1).

Decided510(k)DeviceApplicantDevice type
20 May 2013K122804ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMIntai Technology Corp.DZE Root-Form Endosseous Implant

Registered establishments

EstablishmentLocationWhat it does
INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNITFDA reg. 3011187779Taichung City, TaiwanComplaint file establishment, Contract manufacturer, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10046565). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.