Safety & Quality

Safety & Quality

At EvolveBio Dental, patient safety and clinician confidence come first. We distribute selected dental biomaterial products manufactured by CenoBiologics Ltd. This page explains the standards, controls and practical steps that support safe use, traceability and quality throughout the supply chain—from manufacturer to end user.

1) Professional-use products only

Our products are intended for supply to trained dental professionals and professional organisations. They are not supplied for consumer use.

Clinical decision-making, case selection, technique, patient consent, and compliance with professional guidance remain the responsibility of the treating clinician and the healthcare organisation.

2) Manufacturer and regulatory oversight

The products we distribute are manufactured by CenoBiologics Ltd, a UK tissue establishment listed on the Human Tissue Authority (HTA) register in the Human Application sector.

The HTA register entry includes the licensed activities associated with that establishment (for example, processing, testing, storage, import/export and distribution), as listed on the HTA page above.

CenoBiologics also states that it is an HTA-licensed member of the European Association of Tissue Banks (EATB) and that it adheres to standards monitored by the HTA to meet the European Union Tissues and Cells Directives (EUTCD):
https://cenobiologics.co.uk/

3) What “Safety & Quality” means in practice

Safety and quality are not just statements—they are the day-to-day controls that reduce risk and support predictable workflows. Our approach covers:

A) Product integrity and verification

We support clear identification and verification by:

  • maintaining accurate product and batch/lot information on supply documentation (where applicable)

  • ensuring products are supplied in their original manufacturer packaging and labelling

  • supporting checks on receipt (see section 6)

B) Documentation and transparency

We provide (where available for the products supplied):

  • Instructions for Use (IFUs) and manufacturer documentation

  • supporting product information and evidence links

  • batch/lot details required for traceability and investigation

If you require IFUs, technical sheets or an evidence pack, email: orders@evolvebiodental.com.

C) Controlled distribution and good practice

As a distributor, our role is to support quality by maintaining robust commercial and operational controls, including:

  • clear customer verification (professional-use supply)

  • controlled dispatch processes

  • traceability-supporting records for distribution

  • defined processes for complaints, investigation support, and safety communications

4) Traceability and record-keeping

Traceability is a critical safety requirement for human-derived tissues and related products. In practical terms, this means being able to link the product used back to its identifying information (e.g., lot/batch number), and (where applicable) forward to the recipient record within your organisation.

The HTA’s human application standards set expectations around traceability data and record retention (including retention of minimum traceability data for 30 years after use/expiry/disposal):
https://www.hta.gov.uk/guidance-professionals/guidance-sector/human-application/human-application-sector-hta-standards

What we recommend end users do (best practice)

To support traceability, we recommend that practices and surgical centres:

  • record the product name, lot/batch number, expiry date, and date of use in the clinical record (or implant log)

  • keep copies/photos of the product label where appropriate

  • maintain internal SOPs for biomaterial traceability and stock rotation

  • retain traceability records in line with applicable requirements and your governance policies

If you would like a simple traceability checklist for your practice, email orders@evolvebiodental.com.

5) Storage, handling and clinical use

Correct storage and handling are essential to product performance and safety.

Your responsibilities as an end user

You should:

  • store products strictly in accordance with the IFU and any packaging instructions

  • inspect packaging integrity before use

  • use products only within expiry and only for intended professional use

  • ensure that staff handling the product are trained and familiar with your SOPs and the IFU

If you are unsure about any storage or handling requirement for a product you have received, contact us before use: orders@evolvebiodental.com.

6) Receiving checks (recommended)

When you receive products, we recommend the following quick checks:

  1. Packaging: intact, sealed, not damaged or compromised

  2. Label: correct product, correct size, visible lot/batch and expiry

  3. Documentation: IFU available and accessible to the clinical team

  4. Storage conditions: confirm appropriate storage immediately on receipt

  5. Segregation: quarantine anything that looks unusual and contact us

If there are any concerns, notify us promptly (ideally within 48 hours of delivery) at orders@evolvebiodental.com.

7) Complaints, quality concerns and adverse event reporting

We take all product concerns seriously. If you suspect a quality issue, near miss, or adverse event:

  • stop using the affected product

  • quarantine remaining stock from the same lot/batch

  • retain packaging/labels

  • report to us promptly

Please use our Adverse Event Reporting page for step-by-step guidance and what information to include:
/adverse-event-reporting

Report by email to: orders@evolvebiodental.com (preferred) or info@evolvebiodental.com

Where appropriate, we will coordinate with the Manufacturer and support any required escalation for safety investigation and traceability.

8) Field safety actions and recalls

If a Field Safety Notice, recall, or safety action is required:

  • we will contact affected customers using the details we hold for your organisation

  • we may request confirmation of stock location, quarantine, and any onward distribution

  • we will provide clear instructions for return, replacement, or other actions as applicable

To ensure you receive urgent safety communications, please keep your practice contact details up to date by emailing orders@evolvebiodental.com.

9) Counterfeit, diversion and unauthorised resale

To protect clinicians and patients:

  • we supply only through professional channels

  • products must not be resold, exported, or transferred outside agreed professional supply routes without written permission

  • if you suspect counterfeit, diversion, or unusual supply-chain activity, contact us immediately and do not use the product

10) Data protection (when safety reporting includes personal data)

If you report a complaint or adverse event, we may handle professional contact data and, in limited circumstances, minimal patient-related information where necessary for safety investigation and traceability. We encourage anonymised or pseudonymised reporting wherever possible.

For details, see our Privacy Policy: /privacy-policy

11) Need documentation or a quality pack?

If you need IFUs, a traceability checklist, evidence links, or a practice onboarding pack, contact us:

orders@evolvebiodental.com (preferred)
info@evolvebiodental.com

We’re happy to support single practices and multi-site groups with consistent documentation and workflows.