Smarter Alloys Inc

Address:221 Shearson Cres,Cambridge Ontario,CA

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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

File, Pulp Canal, Endodontic (EKS) (10)

Premarket Exempt

Yes

Clear

Paradigm BX - D948PBXA1N251 Catalog Number : PBX-A1-N25

Device Description : Multi-taper NiTi rotary endodontic file, size A1, 25mm length

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm BX - D948PBXA2N251 Catalog Number : PBX-A2-N25

Device Description : Multi-taper NiTi rotary endodontic file, size A2, 25mm length

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm BX - D948PBXASN251 Catalog Number : PBX-AS-N25

Device Description : Multi-taper NiTi rotary endodontic file, assorted pack, sizes AX-M3, 19-25mm length

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm BX - D948PBXAXN191 Catalog Number : PBX-AX-N19

Device Description : Multi-taper NiTi rotary endodontic file, size AX, 19mm length

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm Quantum - D948PBXLGH251 Catalog Number : PBX-LG-H25

Device Description : .05v taper NiTi reciprocating endodontic file, size large, 25mm length, heat treated

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm Quantum - D948PBXLGN251 Catalog Number : PBX-LG-N25

Device Description : .05v taper NiTi reciprocating endodontic file, size large, 25mm length

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm BX - D948PBXM1N251 Catalog Number : PBX-M1-N25

Device Description : Multi-taper NiTi rotary endodontic file, size M1, 25mm length

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm BX - D948PBXM2N251 Catalog Number : PBX-M2-N25

Device Description : Multi-taper NiTi rotary endodontic file, size M2, 25mm length

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm BX - D948PBXM3N251 Catalog Number : PBX-M3-N25

Device Description : Multi-taper NiTi rotary endodontic file, size M3, 25mm length

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm BX - D948PBXM4N251 Catalog Number : PBX-M4-N25

Device Description : Multi-taper NiTi rotary endodontic file, size M4, 25mm length

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

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