| Primary Device ID | D7692013CO0 |
| NIH Device Record Key | b083799f-033b-49ca-85ce-ae86625de04d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Park Dental Research Corp. |
| Version Model Number | 2013-CO |
| Company DUNS | 011441508 |
| Company Name | PARK DENTAL RESEARCH CORP |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | 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 | 1-800-243-7372 |
| info@pdrus.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7692013CO0 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-14 |
| Device Publish Date | 2015-09-14 |
| D769P90510 | 5.0mm Depth Gauge |
| D769XP33110 | StarVent XP 3.3 x 11 mm Internal Hex Implant w/ Cover Screw |
| D769XP33100 | StarVent XP 3.3 x 10 mm Internal Hex Implant w/ Cover Screw |
| D769XP33080 | StarVent XP 3.3 x 08 mm Internal Hex Implant w/ Cover Screw |
| D769TP400 | 4.0mm StarVent Tissue Punch |
| D769TP350 | 3.5mm StarVent Tissue Punch |
| D769TP300 | 3.0mm StarVent Tissue Punch |
| D769TP250 | 2.5mm Tissue Punch |
| D769TP200 | 2.0mm Tissue Punch |
| D769TP150 | 1.5mm Tissue Punch |
| D769SVKITXP0 | StarVent XP Surgical Kit |
| D769SVKITMT0 | StarVent MT Surgical Kit |
| D769SVKIT10 | Surgical Kit |
| D769P9025S0 | Abutment Driver Short |
| D769P9025L0 | Abutment Driver Long |
| D769P50160 | 5.0 mm x 16 mm StarVent Implant with cover screw and implant driver short |
| D769P50130 | 5.0 mm x 13 mm StarVent Implant with Cover Screw |
| D769P50110 | 5.0 mm x 11.5 mm StarVent Implant with cover screw |
| D769P50100 | 5.0 mm x 10 mm StarVent implant with cover screw |
| D769P50080 | 5.0 mm x 8 mm StarVent Implant with cover screw |
| D769P43130 | 4.2 mm x 13 mm StarVent implant with cover screw |
| D769P42160 | 4.2 mm x 16 mm StarVent Implant with cover screw |
| D769P42110 | 4.2 mm x 11.5 mm StarVent Implant with cover screw and implant driver |
| D769P42100 | 4.2 mm x 10 mm StarVent Implant with cover screw |
| D769P42080 | 4.2 mm x 8 mm StarVent Implant with cover screw and implant driver short |
| D769P38160 | 3.75 mm x 16 mm StarVent Implant with cover screw |
| D769P38130 | 3.75 mm x 13 mm StarVent Implant with Cover Screw |
| D769P38110 | 3.75 mm x 11.5 mm StarVent Implant with cover screw |
| D769P38100 | 3.75 mm x 10 mm StarVent implant with cover and implant driver short |
| D769P38080 | 3.75 mm x 8 mm StarVent implant with cover screw |
| D769P33160 | 3.3 mm x 16 mm StarVent Implant with Cover Screw |
| D769P33100 | 3.3 mm x 10 mm StarVent Implant with cover and implant short driver |
| D769P33080 | 3.3 mm x 8 mm StarVent Implant with cover screw and implant driver short |
| D769P17420 | 4.2mm Irrigated Drill (Outer Ø 3.75) |
| D769P17370 | 3.75mm Irrigated Drill (Outer Ø 3.25mm) |
| D769P17200 | 2.0mm Drill (non-irrigated) (outer Ø 2.0mm) |
| D769OXAN20 | Analog Non-Collared |
| D769OR225 | O-Ring Micro (25 pack) |
| D769OR210 | O-Ring Micro (10 pack) |
| D769OR1100 | O-Ring Large (10 pack) |
| D769OMHP340 | Metal Housing Pink 4 Pack |
| D769OMHP30 | Metal Housing Pink Single Pack |
| D769OMHP240 | Metal Housing Pink 4 Pack |
| D769OMHP20 | Metal Housing Pink Single Pack |
| D769OMHP140 | Metal Housing Pink 4 Pack |
| D769OMHP10 | Metal Housing Pink Large Single Pack |
| D769OKIT10 | Surgical Kit |
| D769OCAN20 | Analog Collared |
| D769NRP10 | NRpiezo + LED Narrow Ridge Piezo Surgical Unit w/LED |
| D769MARK10 | Surgical Marker |