Most dental devices are manufactured from thermoplastic polymers. Most manufacturers have never published any data on what those materials shed during wear. bio. considers this unacceptable.
A retainer is in your mouth overnight, in close contact with saliva and mucous membrane, every night — often for a decade or more. The total material exposure per retainer exceeds almost any other personal care product.
No brand asked the question. We did. And then we published the answer.
"bio. retainers are the only retainers in the UK independently tested for microplastic particle release and confirmed free from harmful microplastics."
This is not a marketing claim. It is a published scientific result. No other retainer brand in the UK has published independent third-party testing data for microplastic particle release — not from dental practices, not from DTC brands, not from the biggest names in the category. They could test theirs. They choose not to.
Most dental device brands never disclose their materials. We built the opposite model: every substance disclosed, every claim tested, every result published.
The bio. Standard is our public material testing protocol. Every product we sell is independently tested by an ISO 17025-accredited laboratory. Every result is published in full below, referenced by product lot number and test date.
If we don't know something, we say so. If we can't support a claim, we don't make it.
| Test | Method | Standard | Laboratory |
|---|---|---|---|
| Microplastic particle release Simulated wear in oral fluid |
Oral simulant extraction at 37°C, 14-day continuous exposure, particle counting by flow cytometry | ISO 10993-12 (extraction), adapted oral exposure protocol | ISO 17025-accredited independent laboratory |
| BPA, BPS, BPF leachate levels | LC-MS/MS analysis of extraction eluate | EU Regulation (EC) No 10/2011 migration limits | ISO 17025-accredited independent laboratory |
| Phthalates | GC-MS extraction and quantification | REACH Annex XVII restriction list | ISO 17025-accredited independent laboratory |
| Heavy metals | ICP-MS on oral simulant after extraction | ISO 10993-13 (polymeric medical devices) | ISO 17025-accredited independent laboratory |
| Biocompatibility — cytotoxicity | L929 fibroblast cell viability assay | ISO 10993-5 (cytotoxicity) | ISO 17025-accredited independent laboratory |
| Polymer composition disclosure | FTIR spectroscopy full spectrum identification | bio. disclosure standard (in-house, published) | ISO 17025-accredited independent laboratory |
Results referenced by product, lot number, and test date. Re-tested on every new production batch.
| Product | Lot Number | Test Date | Laboratory | Report |
|---|---|---|---|---|
| bio.retainers | Lot [XXX] | [Date] | ISO 17025 Accredited | PDF — On file |
| bio.aligners | Lot [XXX] | [Date] | ISO 17025 Accredited | PDF — On file |
Reports will be linked directly as PDF downloads once initial test batches are completed. Lot numbers and dates updated with every new production run.
"bio. retainers are the only retainers in the UK independently tested for microplastic particle release and confirmed free from harmful microplastics."
The data is above. No other retainer brand in the UK has published equivalent independent testing data for microplastic particle release. They could test theirs. They choose not to.
Order bio.retainers →Questions about our testing methodology? Contact hello@bio.uk — we will answer directly.