| Primary Device ID | D0026620101 |
| NIH Device Record Key | 866d6ad3-24a4-4c67-91f9-ca97470e9288 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enhance® PoGo® Polishing System |
| Version Model Number | 662010 |
| Catalog Number | 662010 |
| Company DUNS | 083235549 |
| Company Name | DENTSPLY INTERNATIONAL INC. |
| Device Count | 40 |
| 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 | true |
| 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)532-2855 |
| MilfordDE-Customer-Service@dentsplysirona.com |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0026620100 [Unit of Use] |
| HIBCC | D0026620101 [Primary] |
| HIBCC | D0026620102 [Package] Package: Box [6 Units] In Commercial Distribution |
| DZP | INSTRUMENT, DIAMOND, DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2016-09-21 |
| D002662023Y1 | Enhance PoGo Polishing System Cup Refill - Export Only |
| D0026620231 | Enhance PoGo Polishing System Cup Refill |
| D002662022Y1 | Enhance PoGo Point Refill Package (Export Only) |
| D002662010Y1 | Enhance PoGo Disc Refill - Export Package |
| D0026240241 | Enhance PoGo Sample Package |
| D0026620222 | PoGo® One Step Diamond Micro-Polisher - Polishing Point Refill Package (40) |
| D0026620201 | Enhance® PoGo® COMPLETE Kit |
| D0026620101 | PoGo One Step Diamond Micro-Polisher, DISC Refill Package (40) |
| D002662025Y1 | Enhance® PoGo® Refill Package |
| D0026620241 | Enhance® PoGo® Sample Package |