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, synthetic (LYC) (8) Barrier, animal source, intraoral (NPL) (2)

Premarket Exempt

No Yes

Clear

SYMBIOS® - EFRI9200001041 Catalog Number : 920000104

Device Description : OSTEOGRAF/D-300 (4x1.0g)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : No

Device Count : 1

SYMBIOS® - EFRI9300001041 Catalog Number : 930000104

Device Description : OSTEOGRAF/N-300 (4x1.0g)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

SYMBIOS® - EFRI9300003041 Catalog Number : 930000304

Device Description : OSTEOGRAF/N-300 (4x3.0g)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

SYMBIOS® - EFRI9400000541 Catalog Number : 940000054

Device Description : OSTEOGRAF /LD-300 (4x0.5g)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : No

Device Count : 1

SYMBIOS® - EFRI9400001041 Catalog Number : 940000104

Device Description : OSTEOGRAF/LD-300 (4x1.0g)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : No

Device Count : 1

SYMBIOS® - EFRI9400003041 Catalog Number : 940000304

Device Description : OSTEOGRAF/LD-300 (4x3.0g)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : No

Device Count : 1

SYMBIOS® - EFRI9700001041 Catalog Number : 970000104

Device Description : OSTEOGRAF/N-700 (4x1.0g)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

SYMBIOS® - EFRI9700003041 Catalog Number : 970000304

Device Description : OSTEOGRAF/N-700 (4x3.0g)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

SYMBIOS® - EFRIOSCRM15200 Catalog Number : OSCRM1520

Device Description : OsteoShield® Collagen Resorbable Membrane (15x20mm)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

SYMBIOS® - EFRIOSCRM20300 Catalog Number : OSCRM2030

Device Description : OsteoShield® Collagen Resorbable Membrane (20x30mm)

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : NPL

Prescription Use : Yes

Device Count : 1

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