Duns Number:436664734
Device Description: The Compact Piezo P2K device is an ultrasonic scaler intended for use, with the appropriat The Compact Piezo P2K device is an ultrasonic scaler intended for use, with the appropriate associated insert tips, in the following dental applications:Scaling: All general procedures for removal of supragingival and interdental calculus/plaque deposits.Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning.Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and Retrograde preparation.Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
Catalog Number
04000079
Brand Name
MECTRON
Version/Model Number
COMPACT-PIEZO P2K
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K102218
Product Code
ELC
Product Code Name
Scaler, Ultrasonic
Public Device Record Key
30081f28-9d33-42f5-82d5-229559a1ab48
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 30, 2016
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 | 45 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 199 |