Dental Device Guide
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Manufacturer registered with FDA

Alpha Dent Implants GmbH

Pforzheim, Germany. Lists 3 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.

FDA owner/operator10086730Manufacturer1 clearance in five years
Device types listed
3
Brands and models
176
510(k) clearances
32019–2024
Markets registered in
39 registrations outside the US
Establishments
1Germany
2019: 12021: 12024: 120102020

510(k) clearances per year, 2007–2026

Registered in 3 markets

Where regulators' registries name Alpha Dent Implants GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 3 device types listedTaiwan: 5 registrationsEuropean Union: 4 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerAlpha Dent Implants GmbH3 clearances2019–2024Below
TaiwanTFDAManufacturerAlpha Dent Implants GmbH52018–2025Pure Global AI
European UnionEUDAMEDRegistration holderAlpha Dent Implants GmbH4—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Alpha Dent Implants GmbH 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
dental Implant " Implant Classic_"Dental implant "Zahntium Implant"DENTAL IMPLANT SUPERIOR ACTIVE-ISPA AND ACTIVE BIO PLUS -IABPdental implants "Implant Active Bio_"HCAEK Healing Cap for Aesthetic Abutment KonusHCAEM Healing Cap for Angular Multi-Unit 17°/30°HCAEM Healing Cap wide for Angular Multi-Unit 17°/30°HCAEM- W Healing Cap wide for Angular Multi-Unit 17°/30°HCWK 3/7 Wide Healing CAP 0 5.5 L 7.5HCWK 6.5/3 Wide Healing CAP 0 6.5 L 3.5
82 more
HCWK 6.5/4 Wide Healing CAP 0 6.5 L 4.5HCWK 6.5/5 Wide Healing CAP 0 6.5 L 4.5HCWK 6.5/7 Wide Healing CAP 0 6.5 L 7HCWK 8/3 Wide Healing CAP 0 8 L 3.5HCWK 8/4 Wide Healing CAP 0 8 L 4.5IAB +3.3x10 Implant Active Bio Plus 0 3.3 L 10IAB +3.3x11.5 Implant Active Bio Plus 0 3.3 L 11.5IAB +3.3x13 Implant Active Bio Plus 0 3.3 L 13IAB +3.3x8 Implant Active Bio Plus 0 3.3 L 8IAB +3.75x10 Implant Active Bio Plus 0 3.75 L 10IAB +3.75x11.5 Implant Active Bio Plus 0 3.75 L 11.5IAB +3.75x13 Implant Active Bio Plus 0 3.75 L 13IAB +3.75x16 Implant Active Bio Plus 0 3.75 L 16IAB +3.75x8 Implant Active Bio Plus 0 3.75 L 8IAB +4.2x10 Implant Active Bio Plus 0 4.2 L 10IAB +4.2x11.5 Implant Active Bio Plus 0 4.2 L 11.5IAB +4.2x13 Implant Active Bio Plus 0 4.2 L 13IAB +4.2x16 Implant Active Bio Plus 0 4.2 L 16IAB +4.2x8 Implant Active Bio Plus 0 4.2 L 8IAB +5x10 Implant Active Bio Plus 0 5 L 10IAB +5x8 Implant Active Bio Plus 0 5 L 8IAB +6x11.5 Implant Active Bio Plus 0 6 L 11.5IAB +6x13 Implant Active Bio Plus 0 6 L 13IAB +6x8 Implant Active Bio Plus 0 6 L 8IAB 5x11.5 Implant Active Bio Plus 0 5 L 11.5IAB+ 5x13 Implant Active Bio Plus 0 5 L 13Implant Active Bio Plus 0 3.75 L 8Implant Active Bio Plus 0 Implant Active Bio PlusImplant Active Konus, Implant Classic Konus, Implant Active Bio, PROSTHETIC COMPONENTSImplant Superior Active 0 5.5 L 8Implant Superior Active 0 6 L 10ISPA 3.5x10 Implant Superior Active 0 3.5 L 10ISPA 3.5x11.5 Implant Superior Active 0 3.5 L 11.5ISPA 3.5x13 Implant Superior Active 0 3.5 L 11.5ISPA 3.5x13 Implant Superior Active 0 3.5 L 13ISPA 3.5x16 Implant Superior Active 0 3.5 L 16ISPA 3.5x8 Implant Superior Active 0 3.5 L 8ISPA 4.5x10 Implant Superior Active 0 4.5 L 10ISPA 4.5x11.5 Implant Superior Active 0 4.5 L 11.5ISPA 4.5x13 Implant Superior Active 0 4.5 L 13ISPA 4.5x16 Implant Superior Active 0 4.5 L 16ISPA 4.5x8 Implant Superior Active 0 4.5 L 8ISPA 4x10 Implant Superior Active 0 4 L 10ISPA 4x11.5 Implant Superior Active 0 4 L 11.5ISPA 4x13 Implant Superior Active 0 4 L 13ISPA 4x16 Implant Superior Active 0 3.5 L 16ISPA 4x16 Implant Superior Active 0 4 L 16ISPA 4x8 Implant Superior Active 0 4 L 8ISPA 5.5x10 Implant Superior Active 0 5.5 L 10ISPA 5.5x11.5 Implant Superior Active 0 5.5 L 11.5ISPA 5.5x13 Implant Superior Active 0 5.5 L 13ISPA 5.5x8 Implant Superior Active 0 5.5 L 8ISPA 5x10 Implant Superior Active 0 5 L 10ISPA 5x11.5 Implant Superior Active 0 5 L 11.5ISPA 5x13 Implant Superior Active 0 5 L 13ISPA 5x16 Implant Superior Active 0 5 L 16ISPA 5x8 Implant Superior Active 0 5 L 8ISPA 6x10 IAB +6x10 Implant Active Bio Plus 0 6 L 10ISPA 6x10 Implant Superior Active 0 6 L 10ISPA 6x11.5 Implant Superior Active 0 6 L 11.5ISPA 6x13 Implant Superior Active 0 6 L 13ISPA 6x8 Implant Superior Active 0 6 L 8mplant Active, Active Plus Implants, Implant Active +, Implant Classic, INTEGRAL Implants,Prosthetic Components Sigma ImplantsProsthetic Components ZahntiumSigma ImplantsTAK 3/004 Titanium Abutment Konus 3 4 mmTAK 3/004 Titanium Abutment Konus 3.4 mmTitanium Abutment Konus 3 4 mmWide Healing CAP 0 5.5 L 7.5Wide Healing CAP 0 6.5 L 3.5Wide Healing CAP 0 6.5 L 4.5Wide Healing CAP 0 6.5 L 5.5Wide Healing CAP 0 6.5 L 7Wide Healing CAP 0 8 L 3.5Wide Healing CAP 0 8 L 4.5Wide.Healing CAP 0 6.5.L-5.5Wide.Healing CAP 0 6.5.L-7Wide.Healing CAP 0 8.L-3.5Wide.Healing CAP 0 8.L-4.5Zahntium4.5 L 13 Implant Superior Active 0 4.5 L 13
2022
Endosseous Dental Implant AbutmentNHA · Class 2Implant abutmentsMaker
dental Implant " Implant Classic_"DENTAL IMPLANT SUPERIOR ACTIVE-ISPA AND ACTIVE BIO PLUS -IABPdental implants "Implant Active Bio_"HCAEK Healing Cap for Aesthetic Abutment KonusHCAEM Healing Cap for Angular Multi-Unit 17°/30°HCAEM Healing Cap wide for Angular Multi-Unit 17°/30°HCAEM- W Healing Cap wide for Angular Multi-Unit 17°/30°HCWK 3/7 Wide Healing CAP 0 5.5 L 7.5HCWK 6.5/3 Wide Healing CAP 0 6.5 L 3.5HCWK 6.5/4 Wide Healing CAP 0 6.5 L 4.5
73 more
HCWK 6.5/5 Wide Healing CAP 0 6.5 L 4.5HCWK 6.5/7 Wide Healing CAP 0 6.5 L 7HCWK 8/3 Wide Healing CAP 0 8 L 3.5HCWK 8/4 Wide Healing CAP 0 8 L 4.5IAB +3.3x10 Implant Active Bio Plus 0 3.3 L 10IAB +3.3x11.5 Implant Active Bio Plus 0 3.3 L 11.5IAB +3.3x13 Implant Active Bio Plus 0 3.3 L 13IAB +3.3x8 Implant Active Bio Plus 0 3.3 L 8IAB +3.75x10 Implant Active Bio Plus 0 3.75 L 10IAB +3.75x11.5 Implant Active Bio Plus 0 3.75 L 11.5IAB +3.75x13 Implant Active Bio Plus 0 3.75 L 13IAB +3.75x16 Implant Active Bio Plus 0 3.75 L 16IAB +4.2x10 Implant Active Bio Plus 0 4.2 L 10IAB +4.2x11.5 Implant Active Bio Plus 0 4.2 L 11.5IAB +4.2x13 Implant Active Bio Plus 0 4.2 L 13IAB +4.2x16 Implant Active Bio Plus 0 4.2 L 16IAB +4.2x8 Implant Active Bio Plus 0 4.2 L 8IAB +5x10 Implant Active Bio Plus 0 5 L 10IAB +5x8 Implant Active Bio Plus 0 5 L 8IAB +6x11.5 Implant Active Bio Plus 0 6 L 11.5IAB +6x13 Implant Active Bio Plus 0 6 L 13IAB +6x8 Implant Active Bio Plus 0 6 L 8IAB 5x11.5 Implant Active Bio Plus 0 5 L 11.5IAB+ 5x13 Implant Active Bio Plus 0 5 L 13Implant Active Bio Plus 0 3.75 L 8Implant Active Bio Plus 0 Implant Active Bio PlusImplant Active Konus, Implant Classic Konus, Implant Active Bio, PROSTHETIC COMPONENTSImplant Superior Active 0 5.5 L 8Implant Superior Active 0 6 L 10ISPA 3.5x10 Implant Superior Active 0 3.5 L 10ISPA 3.5x11.5 Implant Superior Active 0 3.5 L 11.5ISPA 3.5x13 Implant Superior Active 0 3.5 L 13ISPA 3.5x16 Implant Superior Active 0 3.5 L 16ISPA 3.5x8 Implant Superior Active 0 3.5 L 8ISPA 4.5x10 Implant Superior Active 0 4.5 L 10ISPA 4.5x11.5 Implant Superior Active 0 4.5 L 11.5ISPA 4.5x16 Implant Superior Active 0 4.5 L 16ISPA 4.5x8 Implant Superior Active 0 4.5 L 8ISPA 4x10 Implant Superior Active 0 4 L 10ISPA 4x11.5 Implant Superior Active 0 4 L 11.5ISPA 4x13 Implant Superior Active 0 4 L 13ISPA 4x16 Implant Superior Active 0 4 L 16ISPA 4x8 Implant Superior Active 0 4 L 8ISPA 5.5x10 Implant Superior Active 0 5.5 L 10ISPA 5.5x11.5 Implant Superior Active 0 5.5 L 11.5ISPA 5.5x13 Implant Superior Active 0 5.5 L 13ISPA 5x10 Implant Superior Active 0 5 L 10ISPA 5x11.5 Implant Superior Active 0 5 L 11.5ISPA 5x13 Implant Superior Active 0 5 L 13ISPA 5x16 Implant Superior Active 0 5 L 16ISPA 5x8 Implant Superior Active 0 5 L 8ISPA 6x10 IAB +6x10 Implant Active Bio Plus 0 6 L 10ISPA 6x11.5 Implant Superior Active 0 6 L 11.5ISPA 6x13 Implant Superior Active 0 6 L 13ISPA 6x8 Implant Superior Active 0 6 L 8mplant Active, Active Plus Implants, Implant Active +, Implant Classic, INTEGRAL Implants,Prosthetic Components Sigma ImplantsSigma ImplantsTAK 3/004 Titanium Abutment Konus 3 4 mmTAK 3/004 Titanium Abutment Konus 3.4 mmTitanium Abutment Konus 3 4 mmWide Healing CAP 0 5.5 L 7.5Wide Healing CAP 0 6.5 L 3.5Wide Healing CAP 0 6.5 L 4.5Wide Healing CAP 0 6.5 L 5.5Wide Healing CAP 0 6.5 L 7Wide Healing CAP 0 8 L 3.5Wide Healing CAP 0 8 L 4.5Wide.Healing CAP 0 6.5.L-5.5Wide.Healing CAP 0 6.5.L-7Wide.Healing CAP 0 8.L-3.5Wide.Healing CAP 0 8.L-4.54.5 L 13 Implant Superior Active 0 4.5 L 13
2022
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
Scan Abutment:ATN9-Ti ; ATN9-P; ATN9 ; ATN-Ti ; AT-MU; Digital Analog: D-ANK3;D-ANAEM
2023

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

510(k) clearances

Clearances on which FDA names Alpha Dent Implants GmbH as the applicant.

Decided510(k)DeviceDevice type
20 Dec 2024K240435Alpha Dent Implants Dental Implants SystemDZE Root-Form Endosseous Implant
1 Nov 2021K210499Alpha Dent Implants Dental Implants SystemDZE Root-Form Endosseous Implant
3 Jul 2019K180968AlphaDent Implants Dental Implants SystemDZE Root-Form Endosseous Implant

Registered establishments

EstablishmentLocationWhat it does
ALPHA DENT IMPLANTS GMBHFDA reg. 3015383403Pforzheim Baden-Wurttemberg, GermanyManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10086730). 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.