DEVICE: Paltop (07290108694796)

Device Identifier (DI) Information

Paltop
60-70136
In Commercial Distribution
60-70136
PALTOP ADVANCED DENTAL SOLUTIONS LTD
07290108694796
GS1

1
533836024 *Terms of Use
Stepped Depth Pin 2.4/3.2
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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
Periodontal probe, reusable A hand-held dental instrument intended to be inserted into a periodontal pocket around a tooth to measure the depth of the periodontal pocket, in order to assess the health of the periodontium and to monitor the progress of disease. It is typically made of high-grade stainless steel and has a distal end with a thin, angled or curved blunt tip with scaled markings to indicate measurements (typically millimetres). This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
DZI Drill, Bone, Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K112795 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Stepped Depth Pin 2.4/3.2
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Device Record Status

5e55a71f-63f2-4552-9263-b5c2cdcf96c6
February 15, 2019
5
January 04, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+97246271711
info@paltopdental.com
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