Biotem Co., ltd

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

Implant, Endosseous, Root-Form (DZE) (10)

Premarket Exempt

No Yes

Clear

Biotem - 08800036200007 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 3.7 mm (D) x 7.5 mm (L)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Biotem - 08800036200014 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 3.7 mm (D) x 8.5 mm (L)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Biotem - 08800036200021 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 3.7 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 - 08800036200038 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 3.7 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 - 08800036200045 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 3.7 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 - 08800036200052 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 3.7 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 - 08800036200069 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 4.2 mm (D) x 7.5 mm (L)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Biotem - 08800036200076 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 4.2 mm (D) X 8.5 mm (L)

Device Class : 2

Duns Number: 557793214

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

Biotem - 08800036200083 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 4.2 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 - 08800036200090 Catalog Number :

Device Description : Biotem NON-MICRO THREAD TYPE AR FIXTURE 4.2 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

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