Bite Blocks

Product Description

The bite blocks offered through Speech Restored are made using BioMed Resin, a high-quality, medical-grade material manufactured by Formlabs in their FDA-registered facility. Each bite block is individually packaged.

This material is produced under a strict Quality Management System certified to ISO 13485 standards and compliant with the EU Medical Device Regulation (MDR). Every batch is created in a certified ISO Class 8 cleanroom by a team of skilled operators and quality assurance professionals.

Formlabs’ Medical Device Resins are both FDA-registered and CE marked, meeting international standards for safety, consistency, and performance.

Safety Warning

• Choking Hazard: The bite block is a small item that poses a significant choking risk. It must be used only as directed by a licensed SLP and under close supervision at all times.
• Age Restriction: Not suitable for children under five (5) years of age.
• Keep Away from Pets: The bite block must never be used near or accessible to pets.
• Supervised Use Required: As the bite block is a choking hazard, adult supervision is required at all times during use.
• Inspection Before Use: Visually inspect the bite block and string before each use to ensure they are intact and undamaged. Do not use it if cracked, damaged, or compromised in any way.
  • When used daily, the bite block typically requires replacement after 2–3 months. Replacement timelines may vary depending on frequency and manner of use.

Return Policy

Due to the personal and hygienic nature of this product, all sales are final. No returns, exchanges, or refunds are permitted once the product has been purchased, opened, or delivered.