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
- [email protected]
- Phone
- 415 9921126
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bur, Dental | EJL | Class 1 | Dental | No | 2006-04-05 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2007-11-25 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2007-11-25 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2006-04-05 |
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