Duns Number:005473608
Device Description: G-CEM LinkForce™ System Kit 3 LinkForce syringes (8.7g) one each of A2, Translucent Opaque G-CEM LinkForce™ System Kit 3 LinkForce syringes (8.7g) one each of A2, Translucent Opaque, 45 regular mixing tips, 5 endo mixing tips with intraoral tip, 1 btl. G-Premio Bond 5mL, 1 btl G-Multi Primer 5mL, 1 btl G-Premio Bond DCA 3mL, 1 syringe GC Etchant 4.8g, 25 dispensing tips+2 covers (for GC Etchant & Try-in Paste), 3 syringe GC Try-in Paste (A2, Translucent, Opaque), 50 disposable applicator, 20 disposable dispensing dish
Catalog Number
009541
Brand Name
G-CEM LinkForce™
Version/Model Number
009541
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K153231,K153231
Product Code
EMA
Product Code Name
CEMENT, DENTAL
Public Device Record Key
4a05a0eb-708f-4f1f-895a-4b8c43948b39
Public Version Date
August 29, 2022
Public Version Number
1
DI Record Publish Date
August 19, 2022
Package DI Number
44548161321830
Quantity per Package
8
Contains DI Package
14548161321839
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |