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
Implant, Endosseous, Root-Form DZE

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