| Primary Device ID | 00810152825891 |
| NIH Device Record Key | 2e939806-c7de-44f2-a8eb-16d5ace422ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ortho Pro |
| Version Model Number | WAX-YL |
| Company DUNS | 085719913 |
| Company Name | Ortho Pro Dent LLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810152825891 [Primary] |
| EGD | Wax, Dental, Intraoral |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-13 |
| Device Publish Date | 2024-11-05 |
| 00810152826300 | lingual sheath Bondable Without Hook or Indent 10 pcs/pk |
| 00810152826294 | lingual sheath Weldable With hook / with indent( mesial R) 10 pcs/pk |
| 00810152826287 | lingual sheath Weldable With hook / with indent (mesial L) 10 pcs/pk |
| 00810152826270 | lingual sheath Weldable With hook /with indent (distal R) 10 pcs/pk |
| 00810152826263 | lingual sheath Weldable With Hook /with indent( distal L) 10 pcs/pk |
| 00810152826256 | lingual sheath Weldable Without Hook with indent 10 pcs/pk |
| 00810152826249 | lingual sheath Weldable Without Hook or Indent 10 pcs/pk |
| 00810152826232 | Lingual Cleats Long 10 pcs/pk |
| 00810152826225 | Lingual Cleats Short 10 pcs/pk |
| 00810152826140 | Crimpable Stops Crimpable Stops Universal 10 pcs/pk |
| 00810152826133 | Crimpable Spiral Hooks Universal Right 10 mm 10 pcs/pk |
| 00810152826126 | Crimpable Spiral Hooks Universal Left 10 mm 10 pcs/pk |
| 00810152826119 | Crimpable Spiral Hooks Universal Right 8.5 mm 10 pcs/pk |
| 00810152826102 | Crimpable Spiral Hooks Universal Left 8.5 mm 10 pcs/pk |
| 00810152826096 | Crimpable Archwire Hooks Universal Right 7.0 mm 10 pcs/pk |
| 00810152826089 | Crimpable Archwire Hooks Universal Left 7.0 mm 10 pcs/pk |
| 00810152826072 | Crimpable Hooks Ball-Top Universal 7.0 mm 10 pcs/pk |
| 00810152826065 | Crimpable Hooks Ball-Top Universal 5.5 mm 10 pcs/pk |
| 00810152826058 | Crimpable Hooks Ball-Top Universal 4.0 mm 10 pcs/pk |
| 00810152826041 | Crimpable Hooks Ball-Top Universal 2.7 mm 10 pcs/pk |
| 00810152826034 | Crimpable Hooks Ball-Top Universal 2.1 mm 10 pcs/pk |
| 00810152826027 | Crimpable Hooks T-Top Universal 7.0 mm 10 pcs/pk |
| 00810152826010 | Crimpable Hooks T-Top Universal 5.5 mm 10 pcs/pk |
| 00810152826003 | Crimpable Hooks T-Top Universal 4.0 mm 10 pcs/pk |
| 00810152825990 | Crimpable Hooks T-Top Universal 2.7 mm 10 pcs/pk |
| 00810152825983 | Crimpable Hooks T-Top Universal 2.1 mm 10 pcs/pk |
| 00810152825976 | Patient Relief Wax Assorted 50pcs/pk |
| 00810152825969 | Patient Relief Wax Osmanthus 50pcs/pk |
| 00810152825952 | Patient Relief Wax Grape 50pcs/pk |
| 00810152825945 | Patient Relief Wax Pineapple 50pcs/pk |
| 00810152825938 | Patient Relief Wax Strawberry 50pcs/pk |
| 00810152825921 | Patient Relief Wax Orange 50pcs/pk |
| 00810152825914 | Patient Relief Wax Apple 50pcs/pk |
| 00810152825907 | Patient Relief Wax Rose 50pcs/pk |
| 00810152825891 | Patient Relief Wax Lemon 50pcs/pk |
| 00810152825884 | Patient Relief Wax Unscented 50pcs/pk |