| Primary Device ID | E312W878K314022101 |
| NIH Device Record Key | d007ae5f-8778-45e0-b0b8-47b194780294 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EDENTA |
| Version Model Number | W878K.314.022 |
| Company DUNS | 448002915 |
| Company Name | EDENTA ETABLISSEMENT |
| Device Count | 3 |
| DM Exempt | true |
| 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 | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E312W878K3140221 [Primary] |
| HIBCC | E312W878K314022101 [Unit of Use] |
| DZP | INSTRUMENT, DIAMOND, DENTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
[E312W878K314022101]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-11 |
| Device Publish Date | 2022-02-03 |