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) (10)

Premarket Exempt

No Yes

Clear

Biotem - 08800036201233 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENT 6.5mm(D)X1.0mm(Cuff)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036201240 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENT 6.5mm(D)X2.0mm(Cuff)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036201257 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENT 6.5mm(D)X3.0mm(Cuff)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036201264 Catalog Number :

Device Description : Biotem AR HEALING ABUTMENT 6.5mm(D)X4.0mm(Cuff)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036201394 Catalog Number :

Device Description : Biotem AR SOLID ABUTMENT 4.5 mm (D) X 1.0 mm (Cuff) X 7.0 mm(H)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036201400 Catalog Number :

Device Description : Biotem AR SOLID ABUTMENT 4.5 mm (D) X 2.0 mm (Cuff) X 7.0 mm(H)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036201417 Catalog Number :

Device Description : Biotem AR SOLID ABUTMENT 4.5 mm (D) X 3.0 mm (Cuff) X 7.0 mm(H)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036201424 Catalog Number :

Device Description : Biotem AR SOLID ABUTMENT 4.5 mm (D) X 4.0 mm (Cuff) X 7.0 mm(H)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036201431 Catalog Number :

Device Description : Biotem AR SOLID ABUTMENT 5.5 mm (D) X 1.0 mm (Cuff) X 7.0 mm(H)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

Biotem - 08800036201448 Catalog Number :

Device Description : Biotem AR SOLID ABUTMENT 5.5 mm (D) X 2.0 mm (Cuff) X 7.0 mm(H)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

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