INTRA-LOCK INTERNATIONAL, INC.

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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) (6) Accessories, Implant, Dental, Endosseous (NDP) (1) Implant, Endosseous, Root-Form (DZE) (1) Platelet And Plasma Separator For Bone Graft Handling (ORG) (1)

Premarket Exempt

No Yes

Clear

Uni Hex - D742UHSA20 Catalog Number : UHSA2

Device Description : UNI HEX STRAIGHT ABUT 2mm Collar

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Uni Hex - D742UHSA30 Catalog Number : UHSA3

Device Description : UNI HEX STRAIGHT ABUT 3mm Collar

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Uni Hex - D742UHTCH0 Catalog Number : UHTCH

Device Description : UNI HEX TITANIUM CYLINDER HEX

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Uni Hex - D742UHTCNH0 Catalog Number : UHTCNH

Device Description : UNI HEX TITANIUM CYLINDER NON HEX

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742WCA0 Catalog Number : WCA

Device Description : WIDE CEMENT ABUTMENT MDL®

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742WCT50 Catalog Number : WCT_50

Device Description : L-PRF White Cap Plain Z Tube (9 ml)

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Intra-Lock - DHRS20 Catalog Number : HRS2

Device Description : Clinical Retaining Screw

Device Class : 1

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

MDL - MDL2008S0 Catalog Number : MLD2008S

Device Description : TRANSITIONAL MDL IMPLANT 2.0MM IMPLANT SINGLE 8MM

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Intra-Lock - S742IBA20 Catalog Number : IBA2

Device Description : O-Ball Abutment Height 2mm, Standard & Wide Platforms, w/ O-Ring Assy

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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