Duns Number:333710619
Device Description: The SURGmatic S15 L Pro handpiece is intended for:• Oral, jaw and facial surgery• Tooth ex The SURGmatic S15 L Pro handpiece is intended for:• Oral, jaw and facial surgery• Tooth extraction procedures• Root resection• Osteotomy• Removal of carious material• Tooth, cavity and crown preparations• Processing of fillingsThe SURGmatic S15 L Pro is for use by a trained professional in the field of generaldentistry and / or oral surgery.
Catalog Number
S15 L Pro
Brand Name
SURGmatic S15 L Pro
Version/Model Number
1.014.4000
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
K213139
Product Code
EGS
Product Code Name
Handpiece, contra- and right-angle attachment, dental
Public Device Record Key
5281cc50-5b1c-4974-97d5-5c592fac9518
Public Version Date
March 21, 2022
Public Version Number
1
DI Record Publish Date
March 11, 2022
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 | 194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 153 |