Primary Device ID | D0026690031 |
NIH Device Record Key | 753c3400-db00-4a70-aacb-a58dd4321077 |
Commercial Distribution Discontinuation | 2024-05-03 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | SmartCem®2 Self-Adhesive Cement |
Version Model Number | 669003 |
Catalog Number | 669003 |
Company DUNS | 083235549 |
Company Name | DENTSPLY INTERNATIONAL INC. |
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 | false |
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 | |
Phone | +1(800)532-2855 |
MilfordDE-Customer-Service@dentsplysirona.com | |
Phone | +1(800)532-2855 |
MilfordDE-Customer-Service@dentsplysirona.com | |
Phone | +1(800)532-2855 |
MilfordDE-Customer-Service@dentsplysirona.com | |
Phone | +1(800)532-2855 |
MilfordDE-Customer-Service@dentsplysirona.com | |
Phone | +1(800)532-2855 |
MilfordDE-Customer-Service@dentsplysirona.com | |
Phone | +1(800)532-2855 |
MilfordDE-Customer-Service@dentsplysirona.com | |
Phone | +1(800)532-2855 |
MilfordDE-Customer-Service@dentsplysirona.com | |
Phone | +1(800)532-2855 |
MilfordDE-Customer-Service@dentsplysirona.com | |
Phone | +1(800)532-2855 |
MilfordDE-Customer-Service@dentsplysirona.com | |
Phone | +1(800)532-2855 |
MilfordDE-Customer-Service@dentsplysirona.com |
Weight | 5 Gram |
Device Size Text, specify | 0 |
Weight | 5 Gram |
Device Size Text, specify | 0 |
Weight | 5 Gram |
Device Size Text, specify | 0 |
Weight | 5 Gram |
Device Size Text, specify | 0 |
Weight | 5 Gram |
Device Size Text, specify | 0 |
Weight | 5 Gram |
Device Size Text, specify | 0 |
Weight | 5 Gram |
Device Size Text, specify | 0 |
Weight | 5 Gram |
Device Size Text, specify | 0 |
Weight | 5 Gram |
Device Size Text, specify | 0 |
Weight | 5 Gram |
Device Size Text, specify | 0 |
Weight | 5 Gram |
Device Size Text, specify | 0 |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D0026690031 [Primary] |
EMA | CEMENT, DENTAL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2024-05-03 |
Device Publish Date | 2016-09-21 |
D0026690041 | SmartCem®2 Self-Adhesive Cement Syringe Sampler |
D0026690031 | SmartCem®2 Self-Adhesive Cement Syringe Evaluator Kit |
D0026690011 | SmartCem®2 Self-Adhesive Cement Syringe Introductory Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SMARTCEM 78539511 3214207 Dead/Cancelled |
CMC SOLUTIONS, LLC 2004-12-29 |
SMARTCEM 77484730 3726244 Live/Registered |
DENTSPLY SIRONA INC. 2008-05-28 |