| Primary Device ID | 00860007845796 |
| NIH Device Record Key | 53cef5e7-9f33-4fc1-9cf8-cbeeaf53f1eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OneBite Evolution |
| Version Model Number | OBEV2010 |
| Catalog Number | OBEV2010 |
| Company DUNS | 081523806 |
| Company Name | Precision Dental Products 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 | true |
| Device Combination Product | false |
| Single Use | true |
| 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 |
|---|---|
| GS1 | 00860007845796 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-22 |
| Device Publish Date | 2025-01-14 |
| 80850031761090 | OneBite Evolution Mounting Table - Artex - LN |
| 70850031761093 | OneBite Evolution Mounting Table - Stratos - LN |
| 60850031761096 | OneBite Evolution Mounting Table - Denar - LN |
| 50850031761099 | OneBite Evolution Mounting Table - Panadent - Std |
| 40850031761092 | OneBite Evolution Mounting Table - Kavo - Std |
| 30850031761095 | OneBite Evolution Mounting Table - Sam - Std |
| 20850031761166 | Midline Bar - Digital Clinician Kit |
| 20850031761098 | OneBite Evolution Mounting Table - Stratos - Std |
| 10850031761626 | OneBite Evolution Radiopaque Markers Replacements |
| 10850031761169 | Midline Bar - Clinician Kit |
| 10850031761091 | OneBite Evolution Mounting Table - Denar - Std |
| 00860007845758 | OneBite Evolution Mounting Table - WhipMix - Std |
| 00860007845741 | OneBite Evolution Clinician Kit |
| 00860007845734 | OneBite Evolution Digital Clinician Kit |
| 00860007845727 | OneBite Evolution Technician Kit - Denar - Std |
| 00860007845710 | OneBite Evolution Mounting Table - Artex - Std |
| 00850031761995 | OneBite Evolution Technician Kit - Stratos - Std |
| 00850031761988 | OneBite Evolution Technician Kit - WhipMix - Std |
| 00850031761971 | OneBite Evolution Technician Kit - Kavo - Std |
| 00850031761964 | OneBite Evolution Technician Kit - Sam - Std |
| 00850031761957 | OneBite Evolution Technician Kit - Panadent - Std |
| 00850031761933 | OneBite Evolution Technician Kit - Stratos - LN |
| 00850031761926 | OneBite Evolution Technician Kit - WhipMix - LN |
| 00850031761919 | OneBite Evolution Technician Kit - Artex - LN |
| 00850031761902 | OneBite Evolution Technician Kit - Sam - LN |
| 00850031761896 | OneBite Evolution Technician Kit - Kavo - LN |
| 00850031761889 | OneBite Evolution Technician Kit - Panadent - LN |
| 00850031761872 | OneBite Evolution Mounting Table - Kavo - LN |
| 00850031761865 | OneBite Evolution Mounting Table - Panadent - LN |
| 00850031761858 | OneBite Evolution Mounting Table - Sam - LN |
| 00850031761841 | OneBite Evolution Mounting Table - WhipMix - LN |
| 00850031761834 | Dental Technician Magnetic Record Kit - 10 |
| 00850031761827 | Dental Technician Magnetic Record Kit |
| 00850031761810 | Evolution Articulator Slider Box |
| 00850031761803 | OneBite Evolution Stylus |
| 00850031761797 | Cube Holder Technician |
| 00850031761780 | Cube Holder Clinician |
| 00850031761773 | Articulator Plate Box |
| 00850031761650 | OneBite Evolution Cube - Digital |
| 00850031761643 | OneBite Evolution Cube - Analog |
| 00850031761629 | OneBite Evolution Radiopaque Markers |
| 00850031761605 | Redundant-OneBite Evolution Technician Kit - Artex - Std |
| 00850031761520 | Nose Extender |
| 00850031761513 | OneBite Screw |
| 00850031761506 | OneBite Evolution Stylus Shaft |
| 00850031761490 | OneBite Evolution Stylus Arm |
| 00850031761483 | OneBite Evolution Stylus Base |
| 00850031761476 | OneBite Arches (24) |
| 00850031761469 | OneBite Arches (6) |
| 00850031761452 | Horizontal and vertical bar (24) |