FAICO MEDICAL LLC

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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

Accessories, Implant, Dental, Endosseous (NDP) (8) Abutment, Implant, Dental, Endosseous (NHA) (2)

Premarket Exempt

No Yes

Clear

AoN Implants - 00840192718051 Catalog Number :

Device Description : Block-Out Spacer, OverDLock Attachment System

Device Class : 1

Duns Number: 081290972

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

AoN Implants - 00840192718068 Catalog Number :

Device Description : Extended Pivot Processing Pack Assembly, OverDLock Attachment System

Device Class : 2

Duns Number: 081290972

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

AoN Implants - 00840192718075 Catalog Number :

Device Description : Extended Pivot Processing Pack Assembly - PVD Cap, OverDLock Attachment System

Device Class : 2

Duns Number: 081290972

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

AoN Implants - 00840192718082 Catalog Number :

Device Description : System Tool (Assembled), OverDLock Attachment System

Device Class : 1

Duns Number: 081290972

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

AoN Implants - 00840192718099 Catalog Number :

Device Description : System Tool End with Holder Sleeve, OverDLock Attachment System

Device Class : 1

Duns Number: 081290972

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

AoN Implants - 00840192718105 Catalog Number :

Device Description : System Tool Tip (Insert Removal), OverDLock Attachment System

Device Class : 1

Duns Number: 081290972

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

AoN Implants - 00840192718112 Catalog Number :

Device Description : System Tool Abutment Holder Sleeve, OverDLock Attachment System

Device Class : 1

Duns Number: 081290972

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

AoN Implants - 00840192718129 Catalog Number :

Device Description : Impression Coping, OverDLock Attachment System

Device Class : 1

Duns Number: 081290972

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

AoN Implants - 00840192718136 Catalog Number :

Device Description : 4mm Lab Analog, OverDLock Attachment System

Device Class : 1

Duns Number: 081290972

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

AoN Implants - 00840192718143 Catalog Number :

Device Description : 5mm Lab Analog, OverDLock Attachment System

Device Class : 1

Duns Number: 081290972

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

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