Primary Device ID | D0026242051 |
NIH Device Record Key | 88cb36b7-f11b-4e7a-ab76-a07cf9e1b6ed |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Enhance® Finishing System/Enhance® PoGo® Polishing System |
Version Model Number | 624205 |
Catalog Number | 624205 |
Company DUNS | 083235549 |
Company Name | DENTSPLY INTERNATIONAL INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 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 |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D0026242051 [Primary] |
EHJ | DISK, ABRASIVE |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-03-23 |
Device Publish Date | 2019-04-02 |
D0016151301 - Celtra® | 2024-11-18 Dentin BL1 |
D0016151311 - Celtra® | 2024-11-18 Dentin BL2 |
D0016151321 - Celtra® | 2024-11-18 Dentin BL3 |
D0016151341 - Celtra® | 2024-11-18 Dentin A1 |
D0016151351 - Celtra® | 2024-11-18 Dentin A2 |
D0016151361 - Celtra® | 2024-11-18 Dentin A3 |
D0016151371 - Celtra® | 2024-11-18 Dentin A3.5 |
D0016151381 - Celtra® | 2024-11-18 Dentin A4 |