Dentsply Implants Manufacturing GmbH

Address:Rodenbacher Chaussee 4,Hanau Hesse,DE

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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

Bone grafting material, dental, with biologic component (NPZ) (5) Bone grafting material, synthetic (LYC) (4) Barrier, animal source, intraoral (NPL) (1)

Premarket Exempt

No Yes

Clear

SYMBIOS® - EFRIOSCRM30400 Catalog Number : OSCRM3040

Device Description : OsteoShield® Collagen Resorbable Membrane (30x40mm)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

SYMBIOS® - EFRIOSNRM12240 Catalog Number : OSNRM1224

Device Description : OsteoShield® PTFE Non-Resorbable Membrane (12x24mm)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

SYMBIOS® - EFRIOSNRM25300 Catalog Number : OSNRM2530

Device Description : OsteoShield® PTFE Non-Resorbable Membrane (25x30mm)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

SYMBIOS® - EFRIOSTRNRM12200 Catalog Number : OSTRNRM1220

Device Description : OsteoShield® Titanium-Reinforced Non-Resorbable Membrane (12x20mm)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

SYMBIOS® - EFRIOSTRNRM25300 Catalog Number : OSTRNRM2530

Device Description : OsteoShield® Titanium-Reinforced Non-Resorbable Membrane (25x30mm)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

Symbios ™ - EFRIUS99U000102 Catalog Number : US99U000102

Device Class :

Duns Number: 344038836

Premarket Exempt : No

Product Code : NPZ

Prescription Use : Yes

Device Count : 2

Symbios ™ - ERFIUS930000104 Catalog Number : US930000104

Device Class :

Duns Number: 344038836

Premarket Exempt : No

Product Code : NPZ

Prescription Use : Yes

Device Count : 4

Symbios ™ - ERFIUS930000304 Catalog Number : US930000304

Device Class :

Duns Number: 344038836

Premarket Exempt : No

Product Code : NPZ

Prescription Use : Yes

Device Count : 4

Symbios ™ - ERFIUS970000104 Catalog Number : US970000104

Device Class :

Duns Number: 344038836

Premarket Exempt : No

Product Code : NPZ

Prescription Use : Yes

Device Count : 4

Symbios ™ - ERFIUS970000304 Catalog Number : US970000304

Device Class :

Duns Number: 344038836

Premarket Exempt : No

Product Code : NPZ

Prescription Use : Yes

Device Count : 4

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