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) (3) Accessories, Implant, Dental, Endosseous (NDP) (3) Platelet And Plasma Separator For Bone Graft Handling (ORG) (2) Implant, Endosseous, Root-Form (DZE) (1) Needle, Hypodermic, Single Lumen (FMI) (1)

Premarket Exempt

No Yes

Clear

Intra-Lock - D74234HA50 Catalog Number : 34HA5

Device Description : EXT HEX 3.4mm HEALING ABUTMENT H:5mm

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Intra-Lock - D7424011TI0 Catalog Number : H4011TI

Device Description : THREADED IMPLANT Ø4mm X 11.5mm

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742BCAA17 Catalog Number : BCAA17

Device Description : Gw Conic Angled Abutment, Wide 17 Deg w/ Retaining Screw

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742BCAA170 Catalog Number : BCAA17

Device Description : Gw Conic Angled Abutment, Wide 17 Deg w/ Retaining Screw

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742BCS0 Catalog Number : BCS

Device Description : Blood Collection Kit

Device Class : 2

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742BDBC0 Catalog Number : BDBC

Device Description : Dual Biomaterial Carrier Spatula

Device Class : 1

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742BDBP0 Catalog Number : BDBP

Device Description : Dual Biomaterial Packer

Device Class : 1

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742BDTRK0 Catalog Number : BDTRK

Device Description : IntraSpin Accessories Kit

Device Class : 1

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

IntraSpin - D742BFUSE1101 Catalog Number : BFUSE110

Device Description : IntraSpin Fuse, IS110

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

IntraSpin - D742BFUSE2201 Catalog Number : BFUSE220

Device Description : IntraSpin Fuse, IS220

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

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