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 |