| Primary Device ID | D010644500701 |
| NIH Device Record Key | b946ca99-cac1-47ac-bd2d-61e8f8fe63a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartLite Focus |
| Version Model Number | 64450070 |
| Catalog Number | 64450070 |
| Company DUNS | 315471722 |
| Company Name | Dentsply De Trey GmbH |
| Device Count | 1 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Outer Diameter | 6.5 Centimeter |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D010644500701 [Primary] |
| EBZ | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-24 |
| Device Publish Date | 2020-12-16 |
| D010644500701 | SmartLite Focus Charging Base is a part of the SmartLite Focus Curing Light and is available sep |
| D010644500501 | SmartLite Focus Power Connector is a part of the SmartLite Focus Curing Light and is available s |
| D010644500400 | SmartLite Focus Eye Protection Sields are a part of the SmartLite Focus Curing Light and are ava |
| D010644500211 | SmartLite Focus Battery Pack is a part of the SmartLite Focus Curing Light and is available sepa |
| D010644500601 | SmartLite Focus Refill is a cordless pen-style, LED light polymerization device for use by train |
| D010644500201 | SmartLite Focus Intro Package is a cordless pen-style, LED light polymerization device for use b |