Device Information

The Endoform Dental Membrane is made from ovine-derived extracellular matrix. It is bioabsorbable, non-crosslinked, and non-reconstituted. It is available in various sizes and thicknesses. Dentists or oral surgeons can trim it to meet individual patient needs.

Indications

The Endoform Dental Membrane is used in extraction sockets and soft tissue grafting. It helps prevent the migration of bone graft material and the loss of alveolar height after tooth extraction.

Intended Use:

The device is for single-use, prescription-only application by dental professionals.

Availability

• Type: Prescription Use Only

Study Results

Nonclinical Testing:

• Collagen and GAG Content: Verified above minimum thresholds.
• DNA Residuals and Proteins: Confirmed safe for use.
• Permeability and Suture Retention: Meets safety and usability standards.
• Sterility and Packaging: Validated for a 36-month shelf life.
• Biocompatibility: Meets ISO 10993 standards.

Regulatory Information

• Regulation Number: 21 CFR 872.3930
• Regulatory Class: Class II
• Product Code: NPL, NPM

The device adheres to the general controls and quality system regulations of 21 CFR 820. Additional specific ISO and ASTM standards ensure sterilization, packaging, and biocompatibility compliance.

Manufacturer Information

• Name: Aroa Biosurgery Ltd.
• Address: 2 Kingsford Smith Place, Airport Oaks, Auckland, 2022, New Zealand
• Contact: Dr. Isabela Monteiro

Predicate Device Information

• Primary Predicate: DynaMatrix T (K082058)
• Secondary Reference Devices:
  • BIO-GIDE (K192042)
  • Endoform Dermal Template (K092096)
• Differences:
  The Endoform Dental Membrane uses ovine tissue, unlike the porcine-derived primary predicate. It offers similar bioabsorption and performance characteristics.

Implications

This Membrane enables effective soft tissue grafting and guided bone regeneration. Compared to its predicates, it does not introduce new safety concerns.

References

1. Endoform Dental Membrane. K231305. Aroa Biosurgery Ltd. FDA Summary. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K231305
2. https://aroa.com/