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) (7) Wire, Orthodontic (DZC) (3)

Premarket Exempt

Yes

Clear

Paradigm BX - D948PBXM5N251 Catalog Number : PBX-M5-N25

Device Description : Multi-taper NiTi rotary endodontic file, size M5, 25mm length

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm Quantum - D948PBXMDH251 Catalog Number : PBX-MD-H25

Device Description : .06v taper NiTi reciprocating endodontic file, size medium, 25mm length, heat treated

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm Quantum - D948PBXMDN251 Catalog Number : PBX-MD-N25

Device Description : .06v taper NiTi reciprocating endodontic file, size medium, 25mm length

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm Quantum - D948PBXPRH251 Catalog Number : PBX-PR-H25

Device Description : .07v taper NiTi reciprocating endodontic file, size primary, 25mm length, heat treated

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm Quantum - D948PBXPRN251 Catalog Number : PBX-PR-N25

Device Description : .07v taper NiTi reciprocating endodontic file, size primary, 25mm length

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm Quantum - D948PBXSMH251 Catalog Number : PBX-SM-H25

Device Description : .07v taper NiTi reciprocating endodontic file, size small, 25mm length, heat treated

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

Paradigm Quantum - D948PBXSMN251 Catalog Number : PBX-SM-N25

Device Description : .07v taper NiTi reciprocating endodontic file, size small, 25mm length

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : EKS

Prescription Use : Yes

Device Count : 6

SmartArch - D948SAODREL18250 Catalog Number :

Device Description : SmartArch .018 x .025" (0.457 x 0.635mm) Round Damon Lower Orthodontic CuNiTi Archwire

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

SmartArch - D948SAODREU18250 Catalog Number :

Device Description : SmartArch .018 x .025" (0.457 x 0.635mm) Round Damon Upper Orthodontic CuNiTi Archwire

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

SmartArch - D948SAODROL00160 Catalog Number :

Device Description : SmartArch .016" (0.406mm) Round Damon Lower Orthodontic CuNiTi Archwire

Device Class : 1

Duns Number: 200106716

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

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