Primary Device ID | D948PBXMDH250 |
NIH Device Record Key | 14f8cd12-9525-4f6f-a48a-35a6cde3bbb6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Paradigm Quantum |
Version Model Number | MDHT |
Catalog Number | PBX-MD-H25 |
Company DUNS | 200106716 |
Company Name | Smarter Alloys Inc |
Device Count | 6 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D948PBXMDH250 [Unit of Use] |
HIBCC | D948PBXMDH251 [Primary] |
EKS | File, Pulp Canal, Endodontic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D948PBXMDH250]
Moist Heat or Steam Sterilization
[D948PBXMDH250]
Moist Heat or Steam Sterilization
[D948PBXMDH250]
Moist Heat or Steam Sterilization
[D948PBXMDH250]
Moist Heat or Steam Sterilization
[D948PBXMDH250]
Moist Heat or Steam Sterilization
[D948PBXMDH250]
Moist Heat or Steam Sterilization
[D948PBXMDH250]
Moist Heat or Steam Sterilization
[D948PBXMDH250]
Moist Heat or Steam Sterilization
[D948PBXMDH250]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-02 |
Device Publish Date | 2021-08-25 |
D948PBXSMH250 | .07v taper NiTi reciprocating endodontic file, size small, 25mm length, heat treated |
D948PBXPRH250 | .07v taper NiTi reciprocating endodontic file, size primary, 25mm length, heat treated |
D948PBXMDH250 | .06v taper NiTi reciprocating endodontic file, size medium, 25mm length, heat treated |
D948PBXLGH250 | .05v taper NiTi reciprocating endodontic file, size large, 25mm length, heat treated |