FDA Registration
Active
🇰🇷 South Korea
FIS41100
Reg #: 3009514134
·
FEI: 3009514134
·
Expires 2025
Products
1
Proprietary Names
486
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WARANTEC Co., Ltd.
- Registration Number
- 3009514134
- FEI Number
- 3009514134
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 411~412, 474, Dunchon-daero, Jungwon-gu
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K081748
Owner / Operator
- Firm Name
- WARANTEC Co., Ltd.
- Operator Number
- 10039281
- Address
- 411~412, 474, Dunchon-daero, Jungwon-gu,
- City
- Sungnam-si
- State
- Gyeonggi
- Postal Code
- 13229
- Country
- KR
- Correspondent
- In Bo Shim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2011-12-21 |
Proprietary Names
FIS41100
FHUT53130B
FHS53130
I0TA4516E
I0AA5036A
IS0ASL
H0AA4348D
H0BA4340
HC0MIP43
IS0MIPP43L
SD-2-L
TD-W11.5 (R)
Ti-I44
FHUT53100
I0SB5034E
I0SB3705E
I0TA3326
I0TA5534
H0AA5334D
H0UA43GH
H0MUGC53
HC0 MAN 53
CD-43
CRD-R10
SA-HH3-LL
SD-54-S
FHT43100
FHUT43130
I0HE6040
I0TA3344
I0TA5514
H0SA3336H
H0AA4334D
HS0IPP53L
H0MUGC33
HC0 MAN 33
S-PD-46
SA-HH3-S
SD-48H-S
FIS41115
FIT53115
FHS33085
FHS53150
I0TA4526E
I0AA5046A
IS0ASS
FIS51150
FHS43115
I0HA5020
I0SB6047E
I0SB5064
H0HA4330
H0AA4358D
H0BA4360
HS0MIPPS
RD
TD-W13 (R)
Ti-I46
I0EA5036E
I0CA37TE
H0BA3320
HC0IPT53H
HC0MUHC53
H0MUPC33
TD-R8.5 (R)
HA-HH
FIS51085
FHT33085
HS0CS53
I0HE5030
I0MA6027E
I0SB6037
I0BA5040
H0HA5320
H0BA5340
HS0IPP33S
H0MUTC33
HC0 UAN 43
TD-R13 (H)
RA-TR-S
FIT53100
FHT53115
I0HA6030
I0SB6035
I0TA4514
I0CA39G
H0HA4320
H0SA4346H
HS0IPT53L
H0UA43GN
H0MU3340
HC0 AN 33
RD-MG-L
RA-TH-S
SA-TH-L
FHT33130
FHUT43100
HS0CS53B
I0HE6020
I0TA3324
IC0IPT40E
H0HA5360
H0AA3334D
HC0IPT43H
HS0IPP43L
H0MU5330
IC0 AN 53
RA-TN-L
FIT53085
FHT53100
I0HA6020
I0SB6025
I0TA3346
IS0IPPLL
H0HA3360
H0SA4336H
HS0IPT53S
H0MU3330
H0MUGPC53
RD-MG-S
RA-HH-LL
SA-HH2-L
FIT43115
FHT43130
FHS53085
I0HA5060
I0SB5046
I0EA6026E
IS0IPPS
H0HA3330
H0SA3366H
H0BA3360
HS0IPT43S
H0MU3310
H0MUGPC33
RA-HH-S
FIS36130
FHUT53085B
I0TA4534E
I0AA5038P
H0AA3348D
HS0UA33G
HC0MM43
HC0MIPP43
S-PD-30
SD-1.5-S
SCD-W13
TD-R13 (R)
I-TAH-R
FIS36150
FHUT53100B
FHS53100
I0TA4544E
I0AA5048P
H0AA3358D
H0BA4320
HS0UA43G
HC0MM53
HC0MIPP53
SD-1.5-L
CRD-N8.5
TD-W8.5 (R)
Ti-I24
FHUT33085
I0HE5010
I0TA4534
IS0UA39G
H0SA5326H
HC0IPP43H
H0UA33PH
H0MU4320
H0TC43TH
HC0 AN 53
SD-30-S
SCD-R10
SA-TR-L
FIS41130
FIT53130
HS0CS33
I0TA4536E
I0SB6017
I0AA5056A
I0BA5020
H0HA4340
H0BA5320
HS0MIPPL
SCD-N8.5
TD-N8.5 (H)
RA-NTH-S
DP
FHT33100
HS0CS33B
I0HE5040
I0SB5024
I0SB6047
I0BA5050
H0HA5330
H0BA5360
HS0IPP33L
H0MUTC43
HC0 UAN 53
TD-W10 (H)
RA-TR-L
FHT33115
HS0CS43B
I0HE6010
I0TA3314
I0BA5060
H0HA5340
HC0IPT33H
HS0IPP43S
H0MU5320
H0MUTC53
IC0 AN 43
RA-TN-S
FHUT33130
FHUT43100B
I0TA4516
I0AA5036P
H0SA5366H
H0AA5346D
H0UA33PN
H0MU5310
H0TC43TN
SD-30-L
RA-MW-L
SCD-W8.5
HD-LT-L
Ti-R
FHT43115
FHUT53085
I0SB5024E
I0TA3316
I0TA5524
H0SA3346H
H0AA5324D
H0UA33GH
H0MUGC43
HC0 MAN 43
CD-38
SA-HH3-L
SD-48H-L
FHUT53130
FHS33100
I0SB5064E
I0SB5035E
I0TA5516
H0AA3346D
H0AA5338D
H0UA33GN
HC0MIPT43
IS0MUTC
TD-36H
CRD-R13
SD-M-S
FHT53130
I0HA6040
I0SB6045
I0TA4524
I0CA39GE
H0SA4366H
HC0IPP33H
H0UA53GN
H0MU4310
FIS36085
FHT43085
FHUT43115
I0HE6030
I0TA3334
I0TA4546
IS0IPTS
H0SA3326H
H0AA4324D
HS0IPP53S
H0MU5340
IC0 MAN 43
RA-SH
HD-TW-L
HC0 AN 43
PD
SCD-R8.5
RA-TH-L
SA-TR-S
FIS41150
IS0CS
HS0CS43
I0TA4546E
I0SB6027
I0BA5030
H0HA4360
H0BA5330
I0MUTC43
HC0 UAN 33
SCD-N13
TD-R10 (H)
RA-NTH-L
FIS51115
FHS43085
I0SB6027E
I0SB5034
I0AA5025E
I0EA5016E
I0MUGC43
HS0AS43
HC0MUHC33
RA-MW-S
CRD-W13
TD-W13 (H)
GPS
TW
FIS51100
FHUT33115B
FHS33150
I0SB6017E
I0TA5546
I0AA5058A
I0MU5040
H0AA4346D
HS0AS33
HS0MUTC
RA-MR-S
CRD-W11.5
GPA
RW
FIS41085
FHUT53115B
FHS53115
I0TA4564E
I0AA5058P
I0EA6046E
H0AA4338D
H0BA4330
HC0MIP33
IS0MIPP43S
SD-2-S
CRD-R8.5
TD-W10 (R)
Ti-I26
FHUT53115
I0SB5044E
I0SB5025E
I0TA5544
H0AA3336D
H0UA53GH
HC0MIPT33
HC0MIP53
HD-MG
CD-53
CRD-R11.5
SD-54-L
FIT43130
FHT53085
I0HA6010
I0SB6015
I0TA3336
I0EA6036E
FIS36115
IS0IPPL
FHUT43130B
I0TA4524E
H0HA3340
I0TA4536
H0SA4326H
I0AA5056P
HS0IPT43L
H0MU3320
H0AA3338D
H0UA53PN
HC0MM33
SD-46-L
HA-MW
SCD-W11.5
TD-R11.5 (R)
HD-TW-S
I-SAH-R
H0MUGPC43
RA-HH-L
SA-HH2-S
FHUT33085B
FHS33115
I0SB5045E
I0TA5526
I0AA5038A
H0AA3356D
H0AA5348D
HC0MIPT53
IS0MUGC
TD-41H
CRD-W8.5
SD-M-L
NH
FIT43100
FHS43150
I0HA5040
I0SB5036
I0EA6016E
IC0IPP43L
H0HA3320
H0BA3340
HS0IPT33L
HS0UA53G
HC0MIPP33
H0MUPC53
HA-TN
FHUT33100
FHUT33130B
I0HE5020
I0TA4544
I0MU5010
H0SA5336H
H0AA4356D
HC0IPP53H
H0UA43PH
H0MU4330
H0TC53TH
SD-35-S
SCD-R11.5
SA-TN-S
FIS51130
FHS43100
I0SB6037E
I0SB5044
I0EA5026E
IC0MIPT43
HS0AS53
HC0MUHC43
I0MUPC43
RA-MR-L
TD-N8.5 (R)
DE
OST
FIS36100
FHUT43085
FHUT43115B
I0TA4526
I0AA5046P
H0AA3324D
H0AA5356D
H0UA43PN
H0TC53TN
SD-35-L
HA-MR
SCD-W10
HD-LT-S
Ti-W
FHUT33100B
FHS33130
I0SB5065E
I0TA5536
I0AA5048A
H0AA4336D
H0AA5358D
H0TC33TH
HS0MUGC
TD-51H
CRD-W10
PG
EW
FHUT33115
FHUT43085B
I0TA4564
I0AA5035E
I0MU5020
H0SA5346H
H0AA5336D
H0UA53PH
H0MU4340
H0TC33TN
SD-46-S
SCD-R13
SA-TN-L
Ti-N
FIT43085
FHS43130
I0HA5030
I0TA4514E
I0SB5026
I0EA5046E
IC0IPP43S
I0CA37T
H0BA3330
HS0IPT33S
IC0MUHC43
H0MUPC43
TD-R10 (R)
HA-TR
Establishment Types
Manufacture Medical Device