ISO 10993-1:202501Biocompatibility Evaluation
Full biological safety assessment per ISO 10993-1:2025 for all device risk classes and patient contact types — from skin contact to long-term implants.
Explore serviceDental · Oral
ISO 7405:2025 Compliance
Biological evaluation of dental materials and devices per ISO 7405:2025.
Overview
What is ISO 7405:2025 compliance?
Dental materials sit in a unique environment: in contact with teeth, pulp, gingiva and oral mucosa, often for years. ISO 7405 sets out the dentistry-specific tests and evaluations that complement the ISO 10993 series.
We support manufacturers of restorative materials, cements, adhesives, implants, orthodontic appliances and aligners, prosthetics and endodontic materials, from evaluation planning to toxicological risk assessment and regulatory documentation.
The result is a biological safety case that meets ISO 7405, ISO 10993 and global regulatory expectations for dental products.
OralEnvironment-specific
DualISO 7405 + ISO 10993
GlobalSubmission ready
When you need it
Typical triggers for this service
- Restorative materials, cements and adhesives
- Dental implants and abutments
- Orthodontic appliances and clear aligners
- Endodontic and pulp-capping materials
- Dentures, crowns, bridges and 3D-printed dental resins
What you receive
Deliverables
01Dental device categorisation
02ISO 7405 and ISO 10993 endpoint mapping
03Test strategy, including pulp and dentine usage tests where required
04Toxicological risk assessment of residual monomers and leachables
05Biological evaluation plan and report
06Regulatory documentation support
Our approach
How we run the engagement
01
Material review
Composition, curing, residual monomers and processing.
02
Categorisation
Oral contact type, site and duration of use.
03
Endpoint mapping
ISO 7405-specific tests alongside ISO 10993 endpoints.
04
Risk assessment
TRA of leachables in the oral environment.
05
Reporting
A complete, submission-ready biological safety case.
Standards & guidance
Aligned with
ISO 7405:2025ISO 10993-1:2025ISO 10993-17:2023ISO 10993-18EU MDR 2017/745FDA dental guidance
FAQs
ISO 7405:2025 Compliance: common questions
ISO 7405 adds dentistry-specific evaluations, such as pulp and dentine usage tests and endodontic usage tests, and guidance on test methods suited to dental materials. It is used together with ISO 10993.
Yes. We assess post-processing, residual monomers and leachables, which are key concerns for printed dental devices.
Yes. We evaluate long-term mucosal and enamel contact for aligners, brackets, wires and related products.
Related services
Often combined with this service
ISO 10993-1:202501
TRA · PDE03Toxicological Risk Assessment
Science-based TRA with quantitative exposure estimates, toxicological thresholds, Margin of safety, and comprehensive conclusions per ISO 10993-18 and 10993-17.
Explore service
Regulatory Compliance02BEP / BER Preparation & Review
End-to-end Biological Evaluation Plans and Reports — regulator-ready, audit-proof, and globally accepted by notified bodies and regulatory authorities.
Explore service
Need iso 7405:2025 compliance for your device?
Talk to a DABT · ERT · UKRT certified toxicologist about your biological evaluation. Direct expert response within 2 hours.
Get In Touch
Do You Have an Enquiry?
We are here to support your safety, compliance & success. Reach out to our certified toxicology experts today.
Tell us about your device
Share a few details and a certified toxicologist will get back to you, usually within 2 hours on business days.