DEVICE: Paltop (07290108691948)

Download: XML | JSON

Device Identifier (DI) Information

Paltop
60-70082
60-70082
PALTOP ADVANCED DENTAL SOLUTIONS LTD
07290108691948
GS1
1
Osteotome For 3.75 Dia. Implant
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DZI Drill, Bone, Powered
CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Osteotome For 3.75 Dia. Implant
CLOSE

Device Status

In Commercial Distribution
December 01, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+97246271711
info@paltopdental.com
CLOSE