FDA Registration Active 🇮🇱 Israel

HI TEC IMPLANTS, LTD.

Reg #: 9613283 · FEI: 3004471724 · Expires 2026
Products
4
Proprietary Names
513
Establishment Types
1
Classifications
4

Registration Details

Registration Name
HI TEC IMPLANTS, LTD.
Registration Number
9613283
FEI Number
3004471724
Status
Active
Expiry Year
2026
Initial Importer
No
Address
20 GALGALEI PLADA ST.
City
HERZLIA Tel Aviv
Country
IL

Regulatory Submissions

510(k) Number
K941575

Owner / Operator

Firm Name
HI TEC IMPLANTS, LTD.
Operator Number
9010116
Address
20 GALGALEI PLADA ST., --
City
HERZLIA
State
IL-NOTA
Postal Code
46722
Country
IL
Correspondent
Dr. Roy Leshem

US Agent

Business Name
Medes USA C/O Matan Arazy
Contact Name
Benzy Arazy
Address
15201 6th Ave Ne
City
Shoreline
State
WA
ZIP
98155
Country
US
Phone
415 9921126

Products

Device Name Product Code
Bur, Dental EJL
Abutment, Implant, Dental, Endosseous NHA
Implant, Endosseous, Root-Form DZE
Accessories, Implant, Dental, Endosseous NDP

Proprietary Names

FSD RTD-EX.IR CSD CSD-EX.IR RB-EX.IR TF 2 FSD-EX.IR PD-EX.IR WTD-EX.IR PD RTD GTD-EX.IR XTD STD NTD TF2.8 TF 3.5 WTD XTD-EX.IR NTD-EX.IR TF 4.2 GTD STD-EX.IR NV-AS-TX SL-BASE W-ANA 15 LP-R SL-RPA SL-ACA-0 B-AS OP-HC NV-MU T-CA-HC AST V-HS-L B-AS-S WTI S-PRN-R T-PRN-R WV-AST SAT W-ACA-P PCA RV-ANA-15 SL-AP MU-PC T-CBA RV-BBA TC-N NV-PRN-R X-FS SL-MU-17/30 RPA-AS-S SL-MU W-PGA T-SCA BBA W-AST ATL FS PC-T NL-HS-P SL-AAT PCA-R LP-HC NV-PRZ-R T-SL-R-N ZTA-T GTI NL-PCA-R SL-PRN-R MU-AAT-L TOI ANA 15 TP-SAT CBA T-NT WV-MU-17/30 T-ZTA GC-R T-HC-W NL-PRN-R MU-FS NL-AAT-L NV-PRZ PT T-AAT-L T-ACA TRX-BA WFR RV-PTA NL-IL T-ACA-W SL-PRN MPI NV-ACA-G NL-BBA OBA NL-ACA-G NL-HC UCLH W-ANA 25 N-AAT-L T-PCA-R SL-HC-A8-5 B-ANA 25 NL-AP-TX W-ACA-E T-PL-R-N WV-ACA-G SL-AS WV-AAT-L TP-BA RV-MU-17/30 PGA T-PL-N SL-AS-S-TX IL WV-MU ZTA T-SL MU-TPC NV-PRN T-IL NV-PCA-R WOI-W T-PRN-W LP-TC WV-HC NL-AAT PC NV-HC BWI W-BBA TRI N-IL T-PCA-W ACA-R SL-PRZ WV-PCA NL-ACA AS-S T-PCA SL-ANA-15 PTA NV-RPA BBA-L LGI PLUS WV-ANA-15 RV-ACA AAT-L TP-IL B-AAT NL-HS T-AS-S RV-ACA-G S-MU-30 WV-PRN-R WV-RPA-15 NL-MU-17/30 W-ANA 15-E OP-IL W-OBA SL-HC-F SL-AST ACA-E B-IL ACA MH CPC RV-TA/C T-PT W-MU BNL NL-ANA-15 RV-PRN RV-RPA WV-PCA-R W-ACA N-AAT SL-PCA-R ACA-0 SL-HC-A7-5 NL-BASE X-HPB G-PT NV-MU-17/30 SL-BBA B-BBA T-OPC LP-IL W-CBA NV-ANA-15 RV-AAT-L TRI-N N-ACA SL-TA/C RV-BASE W-BASE MU-TB B-HS-L SL-PRN-E T-ACA-P RV-PRZ N-BBA B-MU-17/30 TA/C B-HC W-ZTA B-OBA SL-AS-TX NV-AAT RPA-25 NL-HC-F T-AS NL-AS-S-TX T-ANA 20 TC SL-PCA NV-BASE RV-PCA-R TRI-OR B-SAT MU-HS-M T-PC NV-TA/C NV-PCA PRZ W-PRN TW-PRN NV-AS RV-ZTA NL-PGA T-CA-S NPX NL-MU-17/30-2/3/4 NV-AP-TX RPA-15 X-SCA S-MU W-ACA-G HC W-IL WV-ACA RV-AAT EOI-W T-PRN-R-W N-HC W-PCA-R SCA V-AP BTI NL-AS-S MU-HS-L T-OBA N-MU NV-ZTA NL-AP NV-AAT-L NC RV-HC T-AL RV-MU SLT RV-AST SL-HC S-PRN S-BASE T-PRN X-CPC T-HC AS-L T-PL SL-AAT-L CPC-T N-ANA-17-1.5 W-ZTA-R HC-A8-5 T-SL-R ANA 25 T-AF W-ZTA-B W-MU-25 NFR RPA W-SCA NOI WV-PRN WV-RPA NL-AS T-SL-N X-BBA BGI X-AAT V-HS-P ACA-G GC-F MU-CL B-ACA NL-AST TP-SCA W-PRN-R W-HC-P TW-PRN-R TP-CPC G-HC NL-MU N-MU-17/30 NV-RPA-15 L-MH NL-TA/C SL-PGA B-CBA DL RV-PRZ-R RV-T-BASE MU-HC W-PTA TRX-TP NL-RPA X-IL LGI ZTA-B T-IS TRX SL-AP-TX WOI N-PRN S-MU-17/30-2/3/4 NL-PRZ NV-BBA B-HS W-PCA WV-AAT T-AFL UCLN ANL TPI SL-MU-17/30-2/3/4 B-ANA 15 MU-AAT NV-IL NL-HS-L T-PL-R NV-PTA NV-HS-L LP-S NL-RPA-15 ANA 15-E X-HPC X-CPB AS-M W-HC BL CL TRX-OP N-ACA-P ZTA-R HC-A7-5 X-HC V-AS-TX NV-HS T-AAT AS WV-BASE OP-TC W-AAT-L S-MU-17 NPI B-MU NV-ACA WV-PTA TS T-FS TFR SL-ACA-G W-PRZ GL WV-BBA WFR-W NL-PRN NL-PRN-E WV-IL NL-ZTA W-ACA-R T-BBA NV-AST NL-PCA SL-AS-S SL-IL W-AAT AS-SS RV-PRN-R RV-RPA-15 ACA-S V-TS HC-P SL-ZTA SL-ACA RV-IL NV-HS-P V-AP-TX SL-RPA-15 NL-ACA-0 ACA-P VRI AAT RV-PCA WV-LIT-L NL-FT-L HR-TW B-BT II ORT-C MU-IT-Q NL-FT-S NV-LIT-L WV-LIT-S L-AAT MU-AH ITL-S NL-LIT-C BIT-S XTR WV-ILD TIT-S ITL-L RV-LIT-L V-BT-C SL-ILD S-LIT-L G-BT II NV-FT-L SL-SCAN SL-LIT-L MU-SCAN T-LOT SL-FT-S XOT-S LIT-L WV-SCAN NL-LIT-S LIT-S RV-SCAN N-BT II MHT HSD N-FT-S WV-FT-S SHT-S LHT RV-ILD S-FT-L ORT MU-CLD NV-LIT-S ITL-M LHT-L HR TW-SCAN LGT NV-FT-S NL-SCAN EBT ART WV-FT-L L-TOOL RV-LIT-S E-BT-C NL-ILD N-LIT-M RAD XOT-L MU-IT MHT-L MUD W-BT II SL-LIT-S S-SCAN ILD N-LIT-L BIT-L TIT-L NV-ILD S-FT-S DCP VS XTL GSD NL-LIT-L LIT-M T-SCAN CTL LIT-C RV-FT-S NV-SCAN S-BT II RAD-C T-BT-C SL-FT-L W-SCAN T-LIT SHT-L L-BT-C LB-IL S-LIT-M T-RS SHT-C L-BT TIT-C N-SCAN RV-FT-L X-TL SL-LIT-C

Establishment Types

Manufacture Medical Device