FAQ

It’s our first solution for helping dentistry move beyond traditional plastic.

Our patent-pending GT FLEX ® GREEN material is a plant-based plastic alternative that is 100% free from traditional, petroleum-based plastics.

It includes a combination of 100% plant-based, bio-based, and other naturally-occurring components. It’s engineered for dental applications like retainers, aligners, night guards, and oral appliances for sleep apnea.

And it’s formulated specifically to help address concerns about toxicity and microplastics.

GT FLEX ® GREEN is 100% free from traditional, petroleum-based plastics.

In material science, a “plastic” is just a special type of material that can change shape when heated and then keep that new shape when cooled.

That’s it. There’s nothing in the basic definition of “plastic” that says the material must have toxic ingredients or generate long-lasting microplastics. Those generalized concerns are tied to a specific type of plastic – traditional plastic – and stem from the petroleum-derived components used in traditional plastic.

Under the basic, material-science definition, GT FLEX ® GREEN would actually be considered a “plastic” type of material. It needs those cool shape-changing features to be usable for retainers, aligners, night guards, and the like. But it contains none of the petroleum-derived components (nor the related helper chemicals like BPA or phthalates) that are responsible for the growing concerns with traditional plastic.

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.

GT Smiles offers devices made from the GT FLEX ® family of specialty materials for dentistry, including GT FLEX ® PRO, GT FLEX ® MAX, and GT FLEX ® GREEN:

• GT FLEX ® PRO and GT FLEX ® MAX are traditional plastic options that have been proven through years of use by hundreds of thousands of patients and dentists worldwide.
• GT FLEX ® GREEN is our plant-based plastic alternative that is 100% free from traditional plastics.

If it seems odd that a company like ours would continue to offer traditional plastic options, let’s be clear: our goal is to help dentistry move beyond traditional plastic. It’s a journey. And it will take some time for all of us to walk the path together.

So as we continue our work to expand access to GT FLEX ® GREEN to as many dentists and patients as possible – and as we continue to develop GT FLEX ® GREEN options for more and more types of dental devices – our traditional plastic materials remain available as tested and proven options for now.

But GT Smiles is focused on further developing and supporting GT FLEX ® GREEN as the better choice for the future.

It’s already been shown to help some people!

We can’t of course guarantee that it will help:

• Rare allergies: a small portion of the population might be allergic to virtually any material. GT FLEX ® GREEN is no exception here. It’s been used and tested, with no indication that it’s likely to trigger allergic responses. But like almost any material, in a small percentage of people, it could.
• Existing allergies and crossover: sensitivities and allergic responses to certain materials are triggered by complex pathways in the immune system. Sometimes an immune system that develops a response to a truly “bad” thing can later mistake a similar-looking “good” thing as bad and attack it as well (i.e. trigger an allergic reaction).

If your allergies are tied to (and limited to) traditional, petroleum-based plastics, we can tell you that GT FLEX ® GREEN is 100% free from those types of plastics. So it might help you, like it helped Mac.