DEVICE: Paltop (07290108691801)

Device Identifier (DI) Information

Paltop
60-70049
In Commercial Distribution
60-70049
PALTOP ADVANCED DENTAL SOLUTIONS LTD
07290108691801
GS1

1
533836024 *Terms of Use
2.4/2.0 Short Step Twist Drill
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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
Fixture/appliance dental drill bit, reusable A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
DZI Drill, Bone, Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131451 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 2.4/2.0mm Short
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Device Record Status

b998c768-cc6f-4b56-ae98-380c25e33463
November 22, 2018
4
December 01, 2016
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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
Yes
No
No CLOSE

Customer Contact

[?]
+97246271711
info@paltopdental.com
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