DEVICE: Paltop (07290108691948)
Device Identifier (DI) Information
Paltop
60-70082
In Commercial Distribution
60-70082
PALTOP ADVANCED DENTAL SOLUTIONS LTD
60-70082
In Commercial Distribution
60-70082
PALTOP ADVANCED DENTAL SOLUTIONS LTD
Osteotome For 3.75 Dia. Implant
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Dental osteotome | A hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZI | Drill, Bone, Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K131451 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Osteotome For 3.75 Dia. Implant |
Device Record Status
872f9b05-fdae-4204-b31c-a7cacd79bc8f
February 15, 2019
4
December 01, 2016
February 15, 2019
4
December 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+97246271711
info@paltopdental.com
info@paltopdental.com