Night Guard

GUDID 00850073333013

Night Guards are designated to alleviate the pain and damage caused by bruxing or clenching the teeth. Severe tooth, jaw or facial muscle pains are common side effects of bruxing or clenching the teeth. These patients-specific devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching, while protecting teeth from daily wear and tear. Night Guard is shipped non-sterile. Reusable Device /Single consumer, Patient

3D DIAGNOSTIX, INC.

Mouthguard, reusable

• Primary Device ID: 00850073333013
• NIH Device Record Key: c15f02f1-151d-401e-b968-e8d815cdea3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Night Guard
• Version Model Number: Printed Night Guard
• Company DUNS: 004512027
• Company Name: 3D DIAGNOSTIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00850073333013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202465

FDA Product Code

• MQC: Mouthguard, Prescription

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-19
• Device Publish Date: 2025-09-11

Devices Manufactured by 3D DIAGNOSTIX, INC.

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• 00850073333013 - Night Guard: 2025-09-19Night Guards are designated to alleviate the pain and damage caused by bruxing or clenching the teeth. Severe tooth, jaw or facial muscle pains are common side effects of bruxing or clenching the teeth. These patients-specific devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching, while protecting teeth from daily wear and tear. Night Guard is shipped non-sterile. Reusable Device /Single consumer, Patient
• 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