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) (5) Accessories, Implant, Dental, Endosseous (NDP) (5)

Premarket Exempt

Yes No

Clear

Intra-Lock - D742SSAW3NM0 Catalog Number : SSAW3NM

Device Description : Gw No Margin Straight Abutment 3mm collar, w/ Retaining screw

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742SSB0 Catalog Number : SSB

Device Description : SCAN BODY, GOLD STANDARD W/ LAB SCREW

Device Class : 1

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742SSBW0 Catalog Number : SSBW

Device Description : SCAN BODY, GOLD WIDE W/ LAB SCREW

Device Class : 1

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742SSIS0 Catalog Number : SSIS

Device Description : SHORT IMPRESSION SCREW, GOLD & BLUE

Device Class : 1

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Blossom - D742STAB100 Catalog Number : STAB10

Device Description : Gs/Gw Transfer / Abutment Blank, 10º

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Blossom - D742STAB60 Catalog Number : STAB6

Device Description : Gs/Gw Transfer / Abutment Blank, 6º

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742STIBASE0 Catalog Number : STIBASE

Device Description : IntraBase™ for Gold & Blue™ Implants, ST

Device Class : 1

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Intra-Lock - D742STIBASEW0 Catalog Number : STIBASEW

Device Description : IntraBase™ for Gold & Blue™ Implants, WD

Device Class : 1

Duns Number: 131500998

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Blossom - D742STICO0 Catalog Number : STICO

Device Description : Gs Titanium Cylinder w/ Retaining Screw

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Blossom - D742STICOS0 Catalog Number : STICOS

Device Description : Gs Titanium Cylinder, Short

Device Class : 2

Duns Number: 131500998

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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