Duns Number:368788568
Device Description: Planmeca Compact i3 is a dental operative unit with a dental patient chair. The unit is eq Planmeca Compact i3 is a dental operative unit with a dental patient chair. The unit is equipped with a digital control system and a user interface with a touch panel. The instrument console includes five instrument locations, with easy instrument change. The chair and the unit can be swiveled and it is suitable for both right and left-handed use.
Catalog Number
30021331, 30021332
Brand Name
Planmeca Compact
Version/Model Number
i3
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K961420
Product Code
EIA
Product Code Name
Unit, Operative Dental
Public Device Record Key
be709fe4-babe-464d-bcbe-66ddea156ded
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |