Duns Number:119193803
Device Description: Cut gutta percha quickly, cleanly, and safely within the pulp chamber with the cordless GP Cut gutta percha quickly, cleanly, and safely within the pulp chamber with the cordless GP Cut Gutta Percha Cutter. Hold the power button for one second and the tip will reach up to 1,000°C. Release the button, and the tip cools down in less than one second. Bendable, flexible tips come in three sizes: large (2.0mm wide), medium (1.2mm wide), and small (0.5mm wide).The GP Cut system comes complete with one unit, one base, protective cap, and three tips (one of each size). 7-7⁄8" long x 3⁄4" wide. Powered by two AA batteries
Catalog Number
71-36210
Brand Name
GP Cut Gutta Percha Cutter
Version/Model Number
1362
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EKD
Product Code Name
Instrument, Cutting, Operative
Public Device Record Key
11eb1e1b-e95d-476f-a843-49685de1761c
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 19, 2018
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 | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |