Primeprint Splint SF 1000g

GUDID EDET044161

DETAX GmbH

Dental occlusal splint, custom-made

• Primary Device ID: EDET044161
• NIH Device Record Key: c726dd08-1515-44e2-8664-9e5bde3bd629
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primeprint Splint SF 1000g
• Version Model Number: 04416
• Company DUNS: 343947949
• Company Name: DETAX GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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	EDET044161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232448

FDA Product Code

• DYJ: Retainer, Screw Expansion, Orthodontic
• KMY: Positioner, Tooth, Preformed

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: 2023-11-02
• Device Publish Date: 2023-10-25

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