| Primary Device ID | D1355370 |
| NIH Device Record Key | e5944a6c-b900-42cd-bd75-7715848ad171 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DOME Innovation Chair |
| Version Model Number | 537 |
| Catalog Number | 537 |
| Company DUNS | 053883807 |
| Company Name | Dome, Inc. |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Phone | 818-344-3404 |
| info@domeortho.com | |
| Phone | 818-344-3404 |
| info@domeortho.com | |
| Phone | 818-344-3404 |
| info@domeortho.com | |
| Phone | 818-344-3404 |
| info@domeortho.com | |
| Phone | 818-344-3404 |
| info@domeortho.com | |
| Phone | 818-344-3404 |
| info@domeortho.com | |
| Phone | 818-344-3404 |
| info@domeortho.com | |
| Phone | 818-344-3404 |
| info@domeortho.com | |
| Phone | 818-344-3404 |
| info@domeortho.com | |
| Phone | 818-344-3404 |
| info@domeortho.com | |
| Phone | 818-344-3404 |
| info@domeortho.com | |
| Phone | 818-344-3404 |
| info@domeortho.com | |
| Phone | 818-344-3404 |
| info@domeortho.com | |
| Phone | 818-344-3404 |
| info@domeortho.com |
| Length | 68 Inch |
| Length | 68 Inch |
| Length | 68 Inch |
| Length | 68 Inch |
| Length | 68 Inch |
| Length | 68 Inch |
| Length | 68 Inch |
| Length | 68 Inch |
| Length | 68 Inch |
| Length | 68 Inch |
| Length | 68 Inch |
| Length | 68 Inch |
| Length | 68 Inch |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D1355370 [Primary] |
| NRU | Chair, Dental, Without Operative Unit |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D1355370]
Liquid Chemical
[D1355370]
Liquid Chemical
[D1355370]
Liquid Chemical
[D1355370]
Liquid Chemical
[D1355370]
Liquid Chemical
[D1355370]
Liquid Chemical
[D1355370]
Liquid Chemical
[D1355370]
Liquid Chemical
[D1355370]
Liquid Chemical
[D1355370]
Liquid Chemical
[D1355370]
Liquid Chemical
[D1355370]
Liquid Chemical
[D1355370]
Liquid Chemical
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-22 |
| Device Publish Date | 2025-01-14 |
| D1351480 - DOME Coronado Dental Delivery Unit | 2025-01-23 Dental delivery system instrument unit, pneumatic |
| D1355370 - DOME Innovation Chair | 2025-01-22Dental chair, electric |
| D1355370 - DOME Innovation Chair | 2025-01-22 Dental chair, electric |