Manufacturer registered with FDA
Hi-Tec Implants
HERZLIA, Israel. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 899
- 510(k) clearances
- 11994–1994
- Markets registered in
- 36 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name Hi-Tec Implants as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Hi-Tec Implants | 1 clearances | 1994–1994 | Below |
| Taiwan | TFDA | Manufacturer | HI TEC IMPLANTS LTDHI TEC IMPLANTS LTD. | 4 | 2006–2015 | Pure Global AI |
| Israel | AMAR | Manufacturer | HI-TEC IMPLANTSHI-TEC IMPLANTS LTD | 2 | — | 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 Hi-Tec Implants 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 | AATAAT-LACAACA-0ACA-EACA-GACA-PACA-RACA-SANA 15 375 moreANA 15-EANA 25ANLASAS-LAS-MAS-SAS-SSASTATLB-AATB-ACAB-ANA 15B-ANA 25B-ASB-AS-SB-BBAB-CBAB-HCB-HSB-HS-LB-ILB-MUB-MU-17/30B-OBAB-SATBBABBA-LBGIBLBNLBTIBWICBACLCPCCPC-TDLEOI-WFSG-HCG-PTGC-FGC-RGLGTIHCHC-A7-5HC-A8-5HC-PILL-MHLGILGI PLUSLP-HCLP-ILLP-RLP-SLP-TCMHMPIMU-AATMU-AAT-LMU-CLMU-FSMU-HCMU-HS-LMU-HS-MMU-PCMU-TBMU-TPCN-AATN-AAT-LN-ACAN-ACA-PN-ANA-17-1.5N-BBAN-HCN-ILN-MUN-MU-17/30N-PRNNCNFRNL-AATNL-AAT-LNL-ACANL-ACA-0NL-ACA-GNL-ANA-15NL-APNL-AP-TXNL-ASNL-AS-SNL-AS-S-TXNL-ASTNL-BASENL-BBANL-HCNL-HC-FNL-HSNL-HS-LNL-HS-PNL-ILNL-MUNL-MU-17/30NL-MU-17/30-2/3/4NL-PCANL-PCA-RNL-PGANL-PRNNL-PRN-ENL-PRN-RNL-PRZNL-RPANL-RPA-15NL-TA/CNL-ZTANOINPINPXNV-AATNV-AAT-LNV-ACANV-ACA-GNV-ANA-15NV-AP-TXNV-ASNV-AS-TXNV-ASTNV-BASENV-BBANV-HCNV-HSNV-HS-LNV-HS-PNV-ILNV-MUNV-MU-17/30NV-PCA | 2007 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | CSDCSD-EX.IRFSDFSD-EX.IRGTDGTD-EX.IRNTDNTD-EX.IRPDPD-EX.IR 13 moreRB-EX.IRRTDRTD-EX.IRSTDSTD-EX.IRTF 2TF 3.5TF 4.2TF2.8WTDWTD-EX.IRXTDXTD-EX.IR | 2006 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | ARTB-BT IIBIT-LBIT-SCTLDCPDLE-BT-CEBTG-BT II 96 moreGSDHRHR-TWHSDILDITL-LITL-MITL-SL-AATL-BTL-BT-CL-TOOLLB-ILLGTLHTLHT-LLIT-CLIT-LLIT-MLIT-SMHTMHT-LMU-AHMU-CLDMU-ITMU-IT-QMU-SCANMUDN-BT IIN-FT-SN-LIT-LN-LIT-MN-SCANNL-FT-LNL-FT-SNL-ILDNL-LIT-CNL-LIT-LNL-LIT-SNL-SCANNV-FT-LNV-FT-SNV-ILDNV-LIT-LNV-LIT-SNV-SCANORTORT-CRADRAD-CRV-FT-LRV-FT-SRV-ILDRV-LIT-LRV-LIT-SRV-SCANS-BT IIS-FT-LS-FT-SS-LIT-LS-LIT-MS-SCANSHT-CSHT-LSHT-SSL-FT-LSL-FT-SSL-ILDSL-LIT-CSL-LIT-LSL-LIT-SSL-SCANT-BT-CT-LITT-LOTT-RST-SCANTIT-CTIT-LTIT-STW-SCANV-BT-CVSW-BT IIW-SCANWV-FT-LWV-FT-SWV-ILDWV-LIT-LWV-LIT-SWV-SCANX-TLXOT-LXOT-SXTLXTR | 2006 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | AATAAT-LACAACA-0ACA-EACA-GACA-PACA-RACA-SANA 15 375 moreANA 15-EANA 25ANLASAS-LAS-MAS-SAS-SSASTATLB-AATB-ACAB-ANA 15B-ANA 25B-ASB-AS-SB-BBAB-CBAB-HCB-HSB-HS-LB-ILB-MUB-MU-17/30B-OBAB-SATBBABBA-LBGIBLBNLBTIBWICBACLCPCCPC-TDLEOI-WFSG-HCG-PTGC-FGC-RGLGTIHCHC-A7-5HC-A8-5HC-PILL-MHLGILGI PLUSLP-HCLP-ILLP-RLP-SLP-TCMHMPIMU-AATMU-AAT-LMU-CLMU-FSMU-HCMU-HS-LMU-HS-MMU-PCMU-TBMU-TPCN-AATN-AAT-LN-ACAN-ACA-PN-ANA-17-1.5N-BBAN-HCN-ILN-MUN-MU-17/30N-PRNNCNFRNL-AATNL-AAT-LNL-ACANL-ACA-0NL-ACA-GNL-ANA-15NL-APNL-AP-TXNL-ASNL-AS-SNL-AS-S-TXNL-ASTNL-BASENL-BBANL-HCNL-HC-FNL-HSNL-HS-LNL-HS-PNL-ILNL-MUNL-MU-17/30NL-MU-17/30-2/3/4NL-PCANL-PCA-RNL-PGANL-PRNNL-PRN-ENL-PRN-RNL-PRZNL-RPANL-RPA-15NL-TA/CNL-ZTANOINPINPXNV-AATNV-AAT-LNV-ACANV-ACA-GNV-ANA-15NV-AP-TXNV-ASNV-AS-TXNV-ASTNV-BASENV-BBANV-HCNV-HSNV-HS-LNV-HS-PNV-ILNV-MUNV-MU-17/30NV-PCA | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HI TEC IMPLANTS, LTD.FDA reg. 9613283 | HERZLIA Tel Aviv, Israel | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9010116). 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.