3DDX Straight Drill Kit

GUDID 00850073333563

A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

3D DIAGNOSTIX, INC.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00850073333563
• NIH Device Record Key: 07bbe787-5a99-477c-b239-e6692bdec33b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3DDX Straight Drill Kit
• Version Model Number: Dental/maxillofacial surgical procedure kit, non-m
• Company DUNS: 004512027
• Company Name: 3D DIAGNOSTIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850073333563 [Primary]

FDA Product Code

• NYE: Fixture Mount Kit

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00850073333563]

Dry Heat Sterilization

[00850073333563]

Dry Heat Sterilization

[00850073333563]

Dry Heat Sterilization

[00850073333563]

Dry Heat Sterilization

[00850073333563]

Dry Heat Sterilization

[00850073333563]

Dry Heat Sterilization

[00850073333563]

Dry Heat Sterilization

[00850073333563]

Dry Heat Sterilization

[00850073333563]

Dry Heat Sterilization

[00850073333563]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-09-29
• Device Publish Date: 2025-09-10

Devices Manufactured by 3D DIAGNOSTIX, INC.

• 00850073333563 - 3DDX Straight Drill Kit: 2025-09-29A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.
• 00850073333563 - 3DDX Straight Drill Kit: 2025-09-29 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 - Black: 2025-09-19 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 - White: 2025-09-19 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 - Blue: 2025-09-19 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 - Green: 2025-09-19 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 - Yellow: 2025-09-19 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 - Black: 2025-09-19 Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavit