Primosplint

GUDID D831PS100US1

PRIMOTEC LLC

Dental occlusal splint, custom-made Dental occlusal splint, custom-made Dental occlusal splint, custom-made Dental occlusal splint, custom-made Dental occlusal splint, custom-made Dental occlusal splint, custom-made Dental occlusal splint, custom-made Dental occlusal splint, custom-made Dental occlusal splint, custom-made Dental occlusal splint, custom-made Dental occlusal splint, custom-made Dental occlusal splint, custom-made Dental occlusal splint, custom-made Dental occlusal splint, custom-made Dental occlusal splint, custom-made

• Primary Device ID: D831PS100US1
• NIH Device Record Key: dba9a0d8-66de-46fc-b7f6-bd212c2d22f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primosplint
• Version Model Number: PS100US
• Company DUNS: 153454736
• Company Name: PRIMOTEC LLC
• Device Count: 12
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D831PS100US0 [Unit of Use]
HIBCC	D831PS100US1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030832

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: 2021-11-17
• Device Publish Date: 2021-11-09

Devices Manufactured by PRIMOTEC LLC

• D831PS100US1 - Primosplint: 2021-11-17
• D831PS100US1 - Primosplint: 2021-11-17
• D831PS202US0 - primostick: 2021-11-17
• D831PS204US0 - primoglaze: 2021-11-17
• D831PSKIT1 - primosplint system: 2021-11-17
• D831TI10 - PREMIOtitan: 2020-09-07
• D831TI12 - PREMIOtitan: 2020-09-07
• D831TI135 - PREMIOtitan: 2020-09-07
• D831TI15 - PREMIOtitan: 2020-09-07