Duns Number:005473608
Device Description: GC RELINE II™ Intro Kit ExtraExtraSoft contains: 1 GC RELINE II cartridge ExtraExtraSoft GC RELINE II™ Intro Kit ExtraExtraSoft contains: 1 GC RELINE II cartridge ExtraExtraSoft 55g (48mL), 1 GC RELINE II Primer for Resin 8g (10mL), 1 GC RELINE II Point for Trimming, 1 GC Reline II Wheel for Finishing, 1 GC Reline II Remover for Resin 5g (5.5mL), 6 pieces Mixing Tip II L, 3 Disposable brushes, 1 Plastic spatula
Catalog Number
010256
Brand Name
GC RELINE™ II
Version/Model Number
010256
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
K153253
Product Code
EBI
Product Code Name
RESIN, DENTURE, RELINING, REPAIRING, REBASING
Public Device Record Key
30df3cfd-ba6c-44e5-8b85-c45977c4da6d
Public Version Date
August 15, 2022
Public Version Number
1
DI Record Publish Date
August 05, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |