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

Accessories, Implant, Dental, Endosseous (NDP) (4) Implant, Endosseous, Root-Form (DZE) (4) Platelet And Plasma Separator For Bone Graft Handling (ORG) (2)

Premarket Exempt

No Yes

Clear

Blossom - D742BLCT4710S0 Catalog Number : BLCT4710S

Device Description : Wide Platform, Ø4.75 x 10mm, Blossom™ CT Implant, Short Collar

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Blossom - D742BLCT4711S Catalog Number : BLCT4711S

Device Description : Wide Platform, Ø4.75 x 11.5mm, Blossom™ CT Implant, Short Collar

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Blossom - D742BLCT4713S Catalog Number : BLCT4713S

Device Description : Wide Platform, Ø4.75 x 13mm, Blossom™ CT Implant, Short Collar

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Blossom - D742BLCT4713S0 Catalog Number : BLCT4713S

Device Description : Wide Platform, Ø4.75 x 13mm, Blossom™ CT Implant, Short Collar

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742BORH0 Catalog Number : BORH

Device Description : O-Ball Attachment Dia 2.5MM, O-Ring & Assembly

Device Class : 1

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742BPAP0 Catalog Number : BPAP

Device Description : Bone Profiler Alignment Post Standard & Wide

Device Class : 1

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742BPAPSQ0 Catalog Number : BPAPSQ

Device Description : Bone Profiler Alignment Post Square

Device Class : 1

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742BPK0 Catalog Number : BPK

Device Description : Bone Profiler KIt

Device Class : 1

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

IntraSpin - D742BPOWER1101 Catalog Number : BPOWER110

Device Description : IntraSpin Power Cord, 110v

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

IntraSpin - D742BPOWER2201 Catalog Number : BPOWER220

Device Description : IntraSpin Power Cord, 220v

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

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