Manufacturer registered with FDA
Alpha-Bio Tec
Modi'in, Israel. Lists 3 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 406
- 510(k) clearances
- 42007–2026
- Markets registered in
- 5379 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name Alpha-Bio Tec as the manufacturer or the registration holder of a device.
RegisteredHome: IsraelOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Alpha-Bio Tec | 4 clearances | 2007–2026 | Below |
| Colombia | INVIMA | Manufacturer | ALPHA BIO TEC LTD | 298 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ALPHA-BIO TEC LTD. | 35 | 2016–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Alpha Bio TecAlpha-Bio Tec. LTD | 33 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ALPHA-BIO TEC LTD.Alpha Bio Tec Ltd. · Alpha-Bio Tec LTD. | 13 | 2007–2024 | 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-Bio Tec currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Abutment Screw - CSAdhesive Coping for D3.5 MUAngled Ti abutment 10 ° 1.5 CHCAngled Ti abutment 10 ° 1.5 CSAngled Ti abutment 10° 2.5 CHCAngled Ti abutment 10° 2.5 CSAngled Ti abutment 10° 3.5 CHCAngled Ti abutment 10° 3.5 CSAngled Ti abutment 20 ° 1.5 CHCAngled Ti abutment 20 ° 1.5 CS 136 moreAngled Ti abutment 20° 2.5 CHCAngled Ti abutment 20° 2.5 CSAngled Ti abutment 20° 3.5 CHCAngled Ti abutment 20° 3.5 CSASC Adhesive Coping for D3.5 MUCHC screw 60 deg contactDirect conical screwEsthetic Angled Titanium Abutment 15° CHCHealing abutment CHC 2.7 1.5Healing abutment CHC 2.7 2.5Healing abutment CHC 2.7 3.5Healing abutment CHC 2.7 4.5Healing abutment CHC 2.7 5.5Healing abutment CHC 3.8 1.5Healing abutment CHC 3.8 2.5Healing abutment CHC 3.8 3.5Healing abutment CHC 3.8 4.5Healing abutment CHC 3.8 5.5Healing abutment CHC 4.2 1.5Healing abutment CHC 4.2 2.5Healing abutment CHC 4.2 3.5Healing abutment CHC 4.2 4.5Healing abutment CHC 4.2 5.5Healing abutment CS 3.5 1.5Healing abutment CS 3.5 2.5Healing abutment CS 3.5 3.5Healing abutment CS 3.5 4.5Healing abutment CS 3.5 5.5Healing abutment CS 4.3 1.5Healing abutment CS 4.3 2.5Healing abutment CS 4.3 3.5Healing abutment CS 4.3 4.5Healing abutment CS 4.3 5.5Healing abutment CS 5.7 1.5Healing abutment CS 5.7 2.5Healing abutment CS 5.7 3.5Healing abutment CS 5.7 4.5Healing abutment CS 5.7 5.5Healing abutment for D3.5 MU longHealing abutment for D3.5 MU shortHealing abutment for D4.8 MU longHealing abutment for D4.8 MU shortMultiNeO C D3.2mm L10mmMultiNeO C D3.2mm L11.5mmMultiNeO C D3.2mm L13mmMultiNeO C D3.2mm L16mmMultiNeO C D3.2mm L8mmMultiNeO C D3.5mm L10mmMultiNeO C D3.5mm L11.5mmMultiNeO C D3.5mm L13mmMultiNeO C D3.5mm L16mmMultiNeO C D3.5mm L8mmMultiNeO CS D3.75mm L10mmMultiNeO CS D3.75mm L11.5mmMultiNeO CS D3.75mm L13mmMultiNeO CS D3.75mm L16mmMultiNeO CS D3.75mm L8mmMultiNeO CS D4.2mm L10mmMultiNeO CS D4.2mm L11.5mmMultiNeO CS D4.2mm L13mmMultiNeO CS D4.2mm L16mmMultiNeO CS D4.2mm L8mmMultiNeO CS D5mm L10mmMultiNeO CS D5mm L11.5mmMultiNeO CS D5mm L13mmMultiNeO CS D5mm L8mmProsthetic screw MUAStraight Multi unit abutment D3.5H0.75 mm CHCStraight Multi unit abutment D3.5H0.75 mm CSStraight Multi unit abutment D3.5H1.5 mm CHCStraight Multi unit abutment D3.5H1.5 mm CSStraight Multi unit abutment D3.5H2.5 mm CHCStraight Multi unit abutment D3.5H2.5 mm CSStraight Multi unit abutment D3.5H3.5 mm CHCStraight Multi unit abutment D3.5H3.5 mm CSStraight Multi unit abutment D3.5H4.5 mm CHCStraight Multi unit abutment D3.5H4.5 mm CSStraight Multi unit abutment D3.5H5.5 mm CHCStraight Multi unit abutment D3.5H5.5 mm CSStraight Multi unit abutment D4.8 H0.75 mm CSStraight Multi unit abutment D4.8 H0.75mm CHCStraight Multi unit abutment D4.8 H1.5 mm CHCStraight Multi unit abutment D4.8 H1.5 mm CSStraight Multi unit abutment D4.8 H2.5 mm CHCStraight Multi unit abutment D4.8 H2.5 mm CSStraight Multi unit abutment D4.8 H3.5 mm CHCStraight Multi unit abutment D4.8 H3.5 mm CSStraight Multi unit abutment D4.8 H4.5 mm CHCStraight Multi unit abutment D4.8 H4.5 mm CSStraight Multi unit abutment D4.8 H5.5 mm CHCStraight Multi unit abutment D4.8 H5.5 mm CSStraight Ti abutment 0.75 CHCStraight Ti abutment 0.75 CSStraight Ti abutment 1.5 CHCStraight Ti abutment 1.5 CSStraight Ti abutment 2.5 CHCStraight Ti abutment 2.5 CSStraight Ti abutment 3.5 CHCStraight Ti abutment 3.5 CSStraight Ti abutment 4.5 CHCStraight Ti abutment 4.5 CSStraight Ti abutment long CHCStraight Ti abutment long CSTemporary abutment for D3.5 MUTemporary abutment for D4.8 MUTemporary abutment Ti AR 1.5 CHCTemporary abutment Ti AR 1.5 CSTemporary abutment Ti AR 2.5 CHCTemporary abutment Ti AR 2.5 CSTemporary abutment Ti AR 3 narrow CHCTemporary abutment Ti AR 3 narrow CSTemporary abutment Ti AR 3.5 CHCTemporary abutment Ti AR 3.5 CSTemporary abutment Ti AR 4.5 CHCTemporary abutment Ti AR 4.5 CSTemporary abutment Ti R 1.5 CHCTemporary abutment Ti R 1.5 CSTemporary abutment Ti R 2.5 CHCTemporary abutment Ti R 2.5 CSTemporary abutment Ti R 3.5 CHCTemporary abutment Ti R 3.5 CSTemporary abutment Ti R 4.5 CHCTemporary abutment Ti R 4.5 CSTX screw-MU17° Angled Multi unit H1.5 mm CHC17° Angled Multi unit H1.5 mm CS17° Angled Multi unit H2.5 mm CHC17° Angled Multi unit H2.5 mm CS17° Angled Multi unit H3.5 mm CHC17° Angled Multi unit H3.5 mm CS30° Angled Multi unit H1.5 mm CHC30° Angled Multi unit H1.5 mm CS30° Angled Multi unit H2.5 mm CHC30° Angled Multi unit H2.5 mm CS30° Angled Multi unit H3.5 mm CHC30° Angled Multi unit H3.5 mm CS | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Alpha Drill Stopper A-D2-2.4 L10Alpha Drill Stopper A-D2-2.4 L11.5Alpha Drill Stopper A-D2-2.4 L13Alpha Drill Stopper A-D2-2.4 L6Alpha Drill Stopper A-D2-2.4 L8Alpha Drill Stopper B-D2.8-3 L10Alpha Drill Stopper B-D2.8-3 L11.5Alpha Drill Stopper B-D2.8-3 L13Alpha Drill Stopper B-D2.8-3 L6Alpha Drill Stopper B-D2.8-3 L8 104 moreAlpha Drill Stopper C-D3.2-3.65 L10Alpha Drill Stopper C-D3.2-3.65 L11.5Alpha Drill Stopper C-D3.2-3.65 L13Alpha Drill Stopper C-D3.2-3.65 L6Alpha Drill Stopper C-D3.2-3.65 L8Alpha Drill Stopper D-D4.1-4.5 L10Alpha Drill Stopper D-D4.1-4.5 L11.5Alpha Drill Stopper D-D4.1-4.5 L13Alpha Drill Stopper D-D4.1-4.5 L6Alpha Drill Stopper D-D4.1-4.5 L8Alpha Step Drill_2.4/2.8Alpha Step Drill_2.8/3Alpha Step Drill_2.8/3.2Alpha Step Drill_2/2.4Alpha Step Drill_3.2/3.65Alpha Step Drill_3.65/4.1Alpha Step Drill_4.1/4.5Alpha Step Drill_4.5/4.8Alpha Step Drill_4.8/5.2Alpha Straight Drill_D2Analog for D3.5 MUAnalog for D4.8 MUAnalog for printed model CSAnalog Printed Model insertion tool CS/IHCAD/CAM CHC Analog for printed modelCasting sleeve for D3.5 MU RCasting sleeve for D4.8 MU RCHC analog toolClosed tray transfer -CHCClosed tray transfer for D3.5 MUClosed tray transfer for D4.8 MUClosed tray transfer short-CSCountersink Drill D2.7-5.9mmCS Advanced Surgical Organizer BoxDigital analog for D3.5 MUDigital analog for D4.8 MUDrill Extension L17.5mmDrilling Parallel GuideHand Hex Screw Driver 1.25mmHex Driver 1.25mmImplant Analog - CSImplant Analog CHCImplant Depth ProbeImplant Driver Long 2.1mm CHCImplant Driver Long 2.5mm CSImplant Driver Short 2.1mm CHCImplant Driver Short 2.5mm CSImplant Driver Standard 2.1mm CHCImplant Hand Driver 2.1mm CHCLong Hex Driver 1.25mmManual Implant Driver 2.5mm CSManual TX driver angled - StandardManual TX driver angled -LongManual TX driver vertical - LongManual TX driver vertical- StandardMarking DrillMini Surgical Organizer Box W/O SS bathMotor Mount Driver Long 2.1mm CHCMotor Mount Driver Long 2.5mm CSMotor Mount Driver Short 2.1mm CHCMotor Mount Driver Short 2.5mm CSMotor Mount Hex Driver 1.25mmMotor TX driver angled- StandardMotor TX driver angled-LongMotor TX driver vertical -LongMotor TX driver vertical- StandardMU motor straight DriverMU motor straight Driver - LongMU straight DriverOpen tray transfer for D3.5 MU ROpen tray transfer for D4.8 MU ROpen tray transfer Long AR CHCOpen tray transfer Long AR CSOpen tray transfer Long R-CSOpen tray transfer short AR -CSOpen tray transfer short AR CHCOpen tray transfer short R CHCOpen tray transfer short R-CSParallel Depth GuidePlastic cap for closed tray transfer package (10Ratchet TX driver angled - LongRatchet TX driver angled- StandardRatchet TX driver vertical- LongRatchet TX driver vertical- StandardRetrieval ScrewRetrieval Screw CHCRetriever driver MUARound Burr D3mmShort Hand Hex Screw Driver 1.25mmShort Hex Driver 1.25mmShort Parallel Depth GuideSirona CAD/CAM Scan Post-CHCSirona CAD/CAM Scan Post-CSSnap transfer CHCSnap transfer CSStopper Surgical KitSurgical ScrewdriverTrephine Drill D4mmTrephine Drill D5mmTRZ Scan Body CHCTRZ Scan body CSTRZ Scan body for D3.5 MUTRZ Scan body for D4.8 MUUniversal Torque Ratchet 10-45Ncm | 2026 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Abutment Screw - CSAdhesive Coping for D3.5 MUAngled Ti abutment 10 ° 1.5 CHCAngled Ti abutment 10 ° 1.5 CSAngled Ti abutment 10° 2.5 CHCAngled Ti abutment 10° 2.5 CSAngled Ti abutment 10° 3.5 CHCAngled Ti abutment 10° 3.5 CSAngled Ti abutment 20 ° 1.5 CHCAngled Ti abutment 20 ° 1.5 CS 136 moreAngled Ti abutment 20° 2.5 CHCAngled Ti abutment 20° 2.5 CSAngled Ti abutment 20° 3.5 CHCAngled Ti abutment 20° 3.5 CSASC Adhesive Coping for D3.5 MUCHC screw 60 deg contactDirect conical screwEsthetic Angled Titanium Abutment 15° CHCHealing abutment CHC 2.7 1.5Healing abutment CHC 2.7 2.5Healing abutment CHC 2.7 3.5Healing abutment CHC 2.7 4.5Healing abutment CHC 2.7 5.5Healing abutment CHC 3.8 1.5Healing abutment CHC 3.8 2.5Healing abutment CHC 3.8 3.5Healing abutment CHC 3.8 4.5Healing abutment CHC 3.8 5.5Healing abutment CHC 4.2 1.5Healing abutment CHC 4.2 2.5Healing abutment CHC 4.2 3.5Healing abutment CHC 4.2 4.5Healing abutment CHC 4.2 5.5Healing abutment CS 3.5 1.5Healing abutment CS 3.5 2.5Healing abutment CS 3.5 3.5Healing abutment CS 3.5 4.5Healing abutment CS 3.5 5.5Healing abutment CS 4.3 1.5Healing abutment CS 4.3 2.5Healing abutment CS 4.3 3.5Healing abutment CS 4.3 4.5Healing abutment CS 4.3 5.5Healing abutment CS 5.7 1.5Healing abutment CS 5.7 2.5Healing abutment CS 5.7 3.5Healing abutment CS 5.7 4.5Healing abutment CS 5.7 5.5Healing abutment for D3.5 MU longHealing abutment for D3.5 MU shortHealing abutment for D4.8 MU longHealing abutment for D4.8 MU shortMultiNeO C D3.2mm L10mmMultiNeO C D3.2mm L11.5mmMultiNeO C D3.2mm L13mmMultiNeO C D3.2mm L16mmMultiNeO C D3.2mm L8mmMultiNeO C D3.5mm L10mmMultiNeO C D3.5mm L11.5mmMultiNeO C D3.5mm L13mmMultiNeO C D3.5mm L16mmMultiNeO C D3.5mm L8mmMultiNeO CS D3.75mm L10mmMultiNeO CS D3.75mm L11.5mmMultiNeO CS D3.75mm L13mmMultiNeO CS D3.75mm L16mmMultiNeO CS D3.75mm L8mmMultiNeO CS D4.2mm L10mmMultiNeO CS D4.2mm L11.5mmMultiNeO CS D4.2mm L13mmMultiNeO CS D4.2mm L16mmMultiNeO CS D4.2mm L8mmMultiNeO CS D5mm L10mmMultiNeO CS D5mm L11.5mmMultiNeO CS D5mm L13mmMultiNeO CS D5mm L8mmProsthetic screw MUAStraight Multi unit abutment D3.5H0.75 mm CHCStraight Multi unit abutment D3.5H0.75 mm CSStraight Multi unit abutment D3.5H1.5 mm CHCStraight Multi unit abutment D3.5H1.5 mm CSStraight Multi unit abutment D3.5H2.5 mm CHCStraight Multi unit abutment D3.5H2.5 mm CSStraight Multi unit abutment D3.5H3.5 mm CHCStraight Multi unit abutment D3.5H3.5 mm CSStraight Multi unit abutment D3.5H4.5 mm CHCStraight Multi unit abutment D3.5H4.5 mm CSStraight Multi unit abutment D3.5H5.5 mm CHCStraight Multi unit abutment D3.5H5.5 mm CSStraight Multi unit abutment D4.8 H0.75 mm CSStraight Multi unit abutment D4.8 H0.75mm CHCStraight Multi unit abutment D4.8 H1.5 mm CHCStraight Multi unit abutment D4.8 H1.5 mm CSStraight Multi unit abutment D4.8 H2.5 mm CHCStraight Multi unit abutment D4.8 H2.5 mm CSStraight Multi unit abutment D4.8 H3.5 mm CHCStraight Multi unit abutment D4.8 H3.5 mm CSStraight Multi unit abutment D4.8 H4.5 mm CHCStraight Multi unit abutment D4.8 H4.5 mm CSStraight Multi unit abutment D4.8 H5.5 mm CHCStraight Multi unit abutment D4.8 H5.5 mm CSStraight Ti abutment 0.75 CHCStraight Ti abutment 0.75 CSStraight Ti abutment 1.5 CHCStraight Ti abutment 1.5 CSStraight Ti abutment 2.5 CHCStraight Ti abutment 2.5 CSStraight Ti abutment 3.5 CHCStraight Ti abutment 3.5 CSStraight Ti abutment 4.5 CHCStraight Ti abutment 4.5 CSStraight Ti abutment long CHCStraight Ti abutment long CSTemporary abutment for D3.5 MUTemporary abutment for D4.8 MUTemporary abutment Ti AR 1.5 CHCTemporary abutment Ti AR 1.5 CSTemporary abutment Ti AR 2.5 CHCTemporary abutment Ti AR 2.5 CSTemporary abutment Ti AR 3 narrow CHCTemporary abutment Ti AR 3 narrow CSTemporary abutment Ti AR 3.5 CHCTemporary abutment Ti AR 3.5 CSTemporary abutment Ti AR 4.5 CHCTemporary abutment Ti AR 4.5 CSTemporary abutment Ti R 1.5 CHCTemporary abutment Ti R 1.5 CSTemporary abutment Ti R 2.5 CHCTemporary abutment Ti R 2.5 CSTemporary abutment Ti R 3.5 CHCTemporary abutment Ti R 3.5 CSTemporary abutment Ti R 4.5 CHCTemporary abutment Ti R 4.5 CSTX screw-MU17° Angled Multi unit H1.5 mm CHC17° Angled Multi unit H1.5 mm CS17° Angled Multi unit H2.5 mm CHC17° Angled Multi unit H2.5 mm CS17° Angled Multi unit H3.5 mm CHC17° Angled Multi unit H3.5 mm CS30° Angled Multi unit H1.5 mm CHC30° Angled Multi unit H1.5 mm CS30° Angled Multi unit H2.5 mm CHC30° Angled Multi unit H2.5 mm CS30° Angled Multi unit H3.5 mm CHC30° Angled Multi unit H3.5 mm CS | 2026 |
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-Bio Tec as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Oct 2026 | K261295 | MultiNeO Dental Implant System | DZE Root-Form Endosseous Implant |
| 30 Mar 2007 | K063769 | ALPHA BIO BONE FIXATION SCREW SYSTEM | DZL Intraosseous Fixation Screw |
| 26 Mar 2007 | K063770 | ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM | OAT Orthodontic Endosseous Implant |
| 14 Mar 2007 | K063364 | ALPHA BIO DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ALPHA-BIO TECFDA reg. 3016672944 | Modi'in Central, Israel | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095210). 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.