Institut Straumann AG

Address:PETER MERIAN-WEG 12,BASEL Basel-Stadt,CH

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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

Biologic Material, Dental (NQA) (3) Bone grafting material, synthetic (LYC) (3) IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (3) Barrier, synthetic, intraoral (NPK) (1)

Premarket Exempt

No Yes

Clear

Emdogain - 07630031700025 Catalog Number : 075.099

Device Description : Straumann® Emdogain 0.15 ml, Enamel Matrix Derivative 30 mg/ml, contains 5 syrin Straumann® Emdogain 0.15 ml, Enamel Matrix Derivative 30 mg/ml, contains 5 syringes Straumann® Emdogain 0.15 ml and 5 blunt needles

Device Class : 3

Duns Number: 483599259

Premarket Exempt : No

Product Code : NQA

Prescription Use : Yes

Device Count : 1

Emdogain - 07630031700087 Catalog Number : 075.113

Device Description : Emdogain 0.3 ml Multipack USA, contains 3 syringes Emdogain 0.3 ml, 3 syringes P Emdogain 0.3 ml Multipack USA, contains 3 syringes Emdogain 0.3 ml, 3 syringes PrefGel 0.6 ml and 6 blunt needles

Device Class : 3

Duns Number: 483599259

Premarket Exempt : No

Product Code : NQA

Prescription Use : Yes

Device Count : 1

Emdogain - 07630031700100 Catalog Number : 075.115

Device Description : Straumann® Emdogain 0.7 ml, Enamel Matrix Derivative 30 mg/ml, contains 3 syring Straumann® Emdogain 0.7 ml, Enamel Matrix Derivative 30 mg/ml, contains 3 syringes Straumann® Emdogain 0.3 ml, 3 syringesStraumann® PrefGel® 0.6 ml and 6 blunt cannulas

Device Class : 3

Duns Number: 483599259

Premarket Exempt : No

Product Code : NQA

Prescription Use : Yes

Device Count : 1

STRAUMANN MEMBRAGEL - 07630031700148 Catalog Number : 070.101

Device Description : Straumann® MembraGel® 0.8 ml

Device Class : 2

Duns Number: 483599259

Premarket Exempt : No

Product Code : NPK

Prescription Use : Yes

Device Count : 1

STRAUMANN GRANULES - 07630031700155 Catalog Number : 070.203

Device Description : Straumann® BoneCeramic™ 400-700 micrometer, 0.25 g

Device Class : 2

Duns Number: 483599259

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

STRAUMANN GRANULES - 07630031700162 Catalog Number : 070.204

Device Description : Straumann® BoneCeramic™ 500-1000 micrometer, 0.5 g

Device Class : 2

Duns Number: 483599259

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

STRAUMANN GRANULES - 07630031700179 Catalog Number : 070.205

Device Description : Straumann® BoneCeramic™ 500-1000 micrometer, 1.0 g

Device Class : 2

Duns Number: 483599259

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

Straumann 4 mm Short Implants - 07630031700261 Catalog Number : 033.043S

Device Description : Standard Plus Implant, Ø 4.1mm RN, SLActive® 4mm, Roxolid®, Loxim™

Device Class : 2

Duns Number: 483599259

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

STRAUMANN DENTAL IMPLANT SYSTEM - 07630031700278 Catalog Number : 021.2408

Device Description : Bone Level Implant, D 3.3 mm, NC, SLA 8 mm, Ti

Device Class : 2

Duns Number: 483599259

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

STRAUMANN DENTAL IMPLANT SYSTEM - 07630031700285 Catalog Number : 021.2410

Device Description : Bone Level Implant, D 3.3 mm, NC, SLA 10 mm, Ti

Device Class : 2

Duns Number: 483599259

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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