Biotem Co., ltd

Address:# 422, Sasang-ro, Sasang-gu,Busan,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Abutment, Implant, Dental, Endosseous (NHA) (6) Implant, Endosseous, Root-Form (DZE) (4)

Premarket Exempt

No Yes

Clear

Biotem - 08800036200205 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 5.1 mm (D) X 10 mm (L)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Biotem - 08800036200212 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 5.1 mm (D) X 11.5 mm (L)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Biotem - 08800036200229 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 5.1 mm (D) X 13 mm (L)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Biotem - 08800036200236 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 5.1 mm (D) X 15 mm (L)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Biotem - 08800036200953 Catalog Number :

Device Description : Biotem AR CLOSING SCREW

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036200960 Catalog Number :

Device Description : Biotem AR CLOSING SCREW

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036201035 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENT 4.5mm(D)X2.0mm(Cuff)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036201042 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENT 4.5mm(D)X3.0mm(Cuff)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036201059 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENT 4.5mm(D)X4.0mm(Cuff)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036201073 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENT 5.5mm(D)X2.0mm(Cuff)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

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