| Primary Device ID | EKAV100270000 |
| NIH Device Record Key | 40ac3ff6-1796-424b-9fb4-5cbbac5aa1b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIAGNOdent pen 2190 |
| Version Model Number | 1.002.7000 |
| Catalog Number | 2190 |
| Company DUNS | 333710619 |
| Company Name | KaVo Dental GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com | |
| Phone | +18885286872 |
| techservice@kavo.com |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EKAV100270000 [Primary] |
| NTK | Caries detector, laser light, transmission |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-25 |
| Device Publish Date | 2022-04-15 |
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