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

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS (NHA) (5) PLATE, BONE (JEY) (3) Bone grafting material, synthetic (LYC) (2)

Premarket Exempt

No Yes

Clear

FRIADENT® - EFRI324721522 Catalog Number : 47-2152

Device Description : CERCON® Abutment dentin, straight D4.5/GH2/A0

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

FRIADENT® - EFRI324722412 Catalog Number : 47-2241

Device Description : CERCON® Abutment dentin, angled D3.8/GH1/A15

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

FRIADENT® - EFRI324722422 Catalog Number : 47-2242

Device Description : CERCON® Abutment dentin, angled D3.8/GH2/A15

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

FRIADENT® - EFRI324722512 Catalog Number : 47-2251

Device Description : CERCON® Abutment dentin, angled D4.5/GH1/A15

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

FRIADENT® - EFRI324722522 Catalog Number : 47-2252

Device Description : CERCON® Abutment dentin, angled D4.5/GH2/A15

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Symbios® - EFRI325974002 Catalog Number : 32597400

Device Description : Symbios BoneShield oval 20x15 mm

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

Symbios® - EFRI325974012 Catalog Number : 32597401

Device Description : Symbios BoneShield triangular 21x17 mm

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

Symbios® - EFRI325974022 Catalog Number : 32597402

Device Description : Symbios BoneShield rectangular 33x25 mm

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

SYMBIOS® - EFRI9000001041 Catalog Number : 900000104

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

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : No

Device Count : 1

SYMBIOS® - EFRI9000003041 Catalog Number : 900000304

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

Device Class : 2

Duns Number: 344038836

Premarket Exempt : No

Product Code : LYC

Prescription Use : No

Device Count : 1

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