Duns Number:040729840
Device Description: Lingual Curette #45A-46A Opposing 10 Degree Angle 2.5 Millimeter Blades Contra-Angle Shank Lingual Curette #45A-46A Opposing 10 Degree Angle 2.5 Millimeter Blades Contra-Angle Shanks
Catalog Number
-
Brand Name
Lingual Curette
Version/Model Number
1102-SC45A-46A
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"
Yes
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
-
Product Code
EMK
Product Code Name
CURETTE, SURGICAL, DENTAL
Public Device Record Key
784ecc91-bdb0-4ae4-b887-59325cfbc43c
Public Version Date
July 16, 2020
Public Version Number
1
DI Record Publish Date
July 08, 2020
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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |