The material in the replacement teeth

Graphene is added to dental acrylic in the prosthesis. Learn what laboratory tests found, what remains uncertain, and what to ask about care and repairs.

  • 3 min read
  • 4 sections

Updated on

On this page
  1. 01What is in the acrylic
  2. 02What laboratory tests found
  3. 03What 510(k) clearance means
  4. 04Repairs and daily care

According to the doctors at the partner clinics, the technique is called Strategic Corticobasal Implantology. It uses a one-piece implant made of Swiss titanium. The prosthesis has a pure grade 4 titanium frame and a graphene-reinforced nanopolymer, a material used to make the replacement teeth.

The teeth in this prosthesis are made from high-density graphene-reinforced nanopolymer. They are not made of pure graphene. The implants and supporting frame are titanium.

This content is awaiting medical review. The doctor chooses a material after evaluating each case. Hexa Smile coordinates contact and does not prescribe materials or treatments.

What is in the acrylic

Dental acrylic is a resin that can be shaped into replacement teeth. Graphene is a carbon material added in small amounts. The documents reviewed describe it as nanofibers, fibers too small to see with the naked eye.

The laboratory shapes the arch of teeth from a disc of this material. The shape and thickness of the finished piece also affect how it performs. The name of an additive cannot tell you how a particular prosthesis will work.

A pattern of hexagons can help explain graphene’s structure. It does not show what the teeth look like or how much graphene they contain. The prosthesis keeps the color of the dental material.

What laboratory tests found

In 2023, Selva-Otaolaurruchi and colleagues found greater resistance to repeated loading in a laboratory test. They put samples under repeated stress. They did not measure how many years a prosthesis would last in a patient’s mouth.

Also in 2023, De Angelis and colleagues found no significant difference from conventional milled acrylic in bending strength. That test measures how much force a material withstands when bent. One type of test does not replace another.

The research gathered for this page contains little long-term clinical follow-up of full-arch prostheses made with graphene. We cannot give a number of years they will last. The service life offered and coverage terms are to be confirmed.

What 510(k) clearance means

FDA file K220329 documents 510(k) clearance for the dental material. This regulatory pathway compares a product with a reference device. The summary includes laboratory tests and biocompatibility tests, which assess compatibility with the body. No clinical studies in patients were submitted. Clearance is different from approval.

That clearance alone does not establish the outcome of full-mouth treatment. It does not clear the titanium implant. These are separate components, and their documents need separate review.

Repairs and daily care

A prosthesis can wear down or break. Ask what the clinic would do and whether it could repair the piece or would need to replace it. The repair method, cost, and turnaround time are to be confirmed.

Ask the doctor to demonstrate cleaning for the prosthesis you would receive. Discuss which products can be used and what checkups it needs. When comparing materials, ask how maintenance and care back home would differ.

Before accepting a plan, request a quote that identifies both the material of the teeth and the material of the supporting frame.

Sources

  1. 01FDA, expediente 510(k) K220329, 2022accessdata.fda.gov
  2. 02De Angelis y colaboradores, pruebas de materiales, 2023pmc.ncbi.nlm.nih.gov
  3. 03Selva-Otaolaurruchi y colaboradores, fatiga de materiales, 2023pmc.ncbi.nlm.nih.gov

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