Duns Number:078352849
Device Description: Extraction forceps are used to extract teeth. Each extraction forcep is designed for a par Extraction forceps are used to extract teeth. Each extraction forcep is designed for a particular area of the mouth. The beaks are designed to fit around the cervical portion of the tooth.
Catalog Number
Forceps - Extraction
Brand Name
Forceps - Extraction
Version/Model Number
Forceps - Extraction
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 08, 2021
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
-
Product Code
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
0d09464d-5980-4380-a1dd-4a7a6b6704db
Public Version Date
February 11, 2021
Public Version Number
1
DI Record Publish Date
February 03, 2021
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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |