Primary Device ID | 06970873260112 |
NIH Device Record Key | eedba507-5864-4fab-b8fa-00130741ebe2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Endo Rotary file |
Version Model Number | K file, Machine super file, Machine H file, G file |
Company DUNS | 529329650 |
Company Name | DENJOY DENTAL CO.,LTD |
Device Count | 1 |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | true |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06970873260112 [Primary] |
DZN | Instruments, Dental Hand |
Steralize Prior To Use | true |
Device Is Sterile | false |
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
[06970873260112]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-02-28 |
Device Publish Date | 2022-02-19 |
06970873260013 - PULP TESTER | 2022-02-28 |
06970873260051 - Endo Motor | 2022-02-28 |
06970873260068 - Endo Motor | 2022-02-28 |
06970873260075 - Endo Motor | 2022-02-28 |
06970873260082 - Cordless Gutta percha obturation system | 2022-02-28 |
06970873260112 - Endo Rotary file | 2022-02-28K file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal file, OK file, OH file,Taper file, Compliant file and RT fill. |
06970873260112 - Endo Rotary file | 2022-02-28 K file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal file, OK file, OH |
06970873260143 - Gutta percha obturation system | 2022-02-28 |
06970873260167 - Medical Microscope | 2022-02-28 |