Tissue Punch - 4.2mm

GUDID 00850073333556

A dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Sometimes referred to as a mucotome, it will typically be designed with a handle at the proximal end for manual operation or for mounting into a dental power tool (e.g., contra-angle low-speed drill handpiece), and have a cylindrical hollow tube-like head with a sharp cutting at the distal end. It is typically made of high-grade stainless steel. This is a reusable device.

3D DIAGNOSTIX, INC.

Dental soft-tissue coring punch, reusable
Primary Device ID00850073333556
NIH Device Record Keyd5ea3b83-fb19-491f-b5a2-7dcdc51c46e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTissue Punch - 4.2mm
Version Model NumberDental soft-tissue coring punch, reusable / Tissue
Company DUNS004512027
Company Name3D DIAGNOSTIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850073333556 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850073333556]

Dry Heat Sterilization


[00850073333556]

Dry Heat Sterilization


[00850073333556]

Dry Heat Sterilization


[00850073333556]

Dry Heat Sterilization


[00850073333556]

Dry Heat Sterilization


[00850073333556]

Dry Heat Sterilization


[00850073333556]

Dry Heat Sterilization


[00850073333556]

Dry Heat Sterilization


[00850073333556]

Dry Heat Sterilization


[00850073333556]

Dry Heat Sterilization


[00850073333556]

Dry Heat Sterilization


[00850073333556]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-19
Device Publish Date2025-09-11

Devices Manufactured by 3D DIAGNOSTIX, INC.

00850073333563 - 3DDX Straight Drill Kit2025-09-29 A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dent
00850073333013 - Night Guard 2025-09-19 Night Guards are designated to alleviate the pain and damage caused by bruxing or clenching the teeth. Severe tooth, jaw or faci
00850073333136 - Straight Drill LSD 02.75x15 - Black2025-09-19 Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavit
00850073333143 - Straight Drill LSD 02.75x18 - White2025-09-19 Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavit
00850073333150 - Straight Drill LSD 02.75x20 - Blue2025-09-19 Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavit
00850073333167 - Straight Drill LSD 02.75x23 - Green2025-09-19 Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavit
00850073333174 - Straight Drill LSD 02.75x25 - Yellow2025-09-19 Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavit
00850073333198 - Straight Drill LSD 03.15x15 - Black2025-09-19 Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavit

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