| Primary Device ID | D769OR125 |
| NIH Device Record Key | 87d0672e-a076-401c-bbcb-ecdce1c88ea9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Park Dental Research Corp |
| Version Model Number | OR-125 |
| Company DUNS | 011441508 |
| Company Name | PARK DENTAL RESEARCH CORP |
| Device Count | 25 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 1-800-243-7372 |
| info@pdrus.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D769OR125 [Primary] |
| HIBCC | H7000325 [Unit of Use] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2015-11-09 |
| D769P90410 | 4.2 mm Depth Gauge |
| D769P90380 | 3.75mm Depth Gauge |
| D769P90330 | 3.3 mm Depth Gauge |
| D769RATC800 | Continuous Feedback Torque Wrench 15-80 Ncm |
| D769P33110 | 3.3 mm x 11.5 mm StarVent Implant with cover screw and implant driver short |
| D769P17500 | 5.0mm Irrigated Drill (Outer Ø 4.5mm) |
| D769OR125 | O-Ring Large (25 pack) |
| D769OKIT20 | Deluxe Surgical Kit |
| D769DRVRT2040 | 3.0 Multi-Purpose Driver 2.04 mm / 2.0 mm O-Ball Abutment Driver Short |
| D769DRT150 | 1.5mm Surgical Drill |
| D769ACAN30 | 3.0mm Multi-Platform Analog |
| D7692513XO0 | 2.5 mm X 13 mm LEW Mini Implant Non-Collared |