KeyPrint KeySplint Soft

GUDID 00810002220173

The KeyPrint KeySplint Soft device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, and repositioners.

JOHN'S DENTAL LABORATORY INC

Dental appliance fabrication material, resin

• Primary Device ID: 00810002220173
• NIH Device Record Key: 09b06cad-4a69-4ca9-8d87-38a8b29ffeb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KeyPrint KeySplint Soft
• Version Model Number: 3014680794
• Company DUNS: 016649253
• Company Name: JOHN'S DENTAL LABORATORY 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: false
• 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	00810002220173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183598

FDA Product Code

• MQC: Mouthguard, Prescription

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-12
• Device Publish Date: 2023-04-04