— THE BIO. STANDARD

The bio.
Standard.

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.

— WHY THIS MATTERS

8 hours every night.
For years.

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.

— THE CLAIM

"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.

— THE BIO. MATERIAL DIFFERENCE

What bio. is made of.

Most dental device brands never disclose their materials. We built the opposite model: every substance disclosed, every claim tested, every result published.

100% Microplastic-Free

No unstable plastics that fragment and leach into your body over time. bio. materials are independently tested for microplastic particle release under simulated wear conditions — confirmed below detection limits.

CONFIRMED BY ISO 17025 LAB

I

Advanced Organic Polymers

Formulated from biocompatible organic polymers derived from plant-based sources. Extreme durability, long-term safety. Full polymer composition disclosed by FTIR spectroscopy — a standard no other UK brand meets

PLANT-DERIVED  •  BPA-FREE  •  PHTHALATE-FREE

II

Independently Tested

Every production batch tested by an ISO 17025-accredited laboratory. Results for BPA, BPS, BPF, phthalates, heavy metals, and microplastic release published in full by lot number. Re-tested on every new production run.

READ FULL RESULTS AT BIO.UK/STANDARD →

III

— TESTING PROTOCOL

Our testing protocol.

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

— PUBLISHED RESULTS

Published results.

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 in Lot numbers and dates updated with every new production run.

— THE PLAIN STATEMENT

"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.

Questions about our testing methodology? Contact hello@bio.uk — we will answer directly.