That’s one of the key goals in switching from petroleum-based components (used in traditional plastics) to 100% plant-based, bio-based, and other naturally-occurring components (used in GT FLEX ® GREEN).
But you still have test – and we did.
GT FLEX ® GREEN has been evaluated by independent, third-party testing laboratories for multiple safety-related criteria. The results indicate that GT FLEX ® GREEN is a safe, non-toxic solution for a variety of intraoral devices.
Biocompatibility Testing
Materials used for aligners, retainers, night guards, and the like generally must pass at least the following three biocompatibility tests:
- In Vitro Cytotoxicity (ISO 10993-5:2009)
- Skin Sensitization (ISO 10993-10:2021)
- Skin Irritation (ISO 10993-23:2021 – tests for Irritation)
GT FLEX ® GREEN has passed those three tests plus three additional tests we added for a more thorough evaluation:
- Oral Mucosa Irritation (ISO 10993-23:2021 – tests for Irritation)
- Acute Systemic Toxicity (ISO 10993-11:2017 – tests for Systemic Toxicity)
- Material Mediated Pyrogenicity (ISO 10993-11:2017 – tests for Systemic Toxicity)
Extractables and Leachables (E&L) Testing
GT FLEX ® GREEN is formulated intentionally to be degradable (it’s a required feature for addressing microplastics concerns), so it’s even more important for us to evaluate what might get released from the material as it starts to degrade.
To address this question, we submitted the material for extensive “extractables and leachables” testing.
In these tests, the material is subjected to “worst case scenario” conditions (e.g. much stronger acids than would be present in the mouth) in order to try to get it to degrade as quickly as possible. The resulting mix of extracted and leached substances is then tested for the presence of each of following:
- Elemental Impurities
- Volatile Organic Compounds
- Semi-Volatile Organic Compounds
- Non-Volatile Organic Compounds
These tests found no cause for concern from anything extracted from GT FLEX ® GREEN, even under “worst case” conditions triggering aggressive degradation.