DentalChain
Dental Implant Tracking
End-to-end traceability for every dental implant, every patient.
DentalChain connects every participant in the dental implant supply chain — manufacturer, distributor, dental clinic, dentist, and regulatory authority — on a single, shared, tamper-proof Hyperledger Fabric ledger. Every device is tracked from the manufacturing facility to the patient's jaw.
Dental implant failures, counterfeit fixtures, and delayed recalls are a growing global problem. When a manufacturer issues a recall on a contaminated implant batch, dental clinics must identify affected patients manually — a process that can take days or weeks. DentalChain makes it one second. Every lot is traceable, every placement event is permanently recorded, and recall response is instantaneous.
Demo Preview
DentalChain — Interactive Demo
Recall Response Time
1 Second
Today's Reality
Days–Weeks
Regulatory Frameworks
6 Covered
MVP Status
✅ Live
Logic Layer
Manufacturer
Lot created on-chain — requires valid FDA clearance + ISO 13485 cert enforced by smart contract
Distributor / Rep
Consignment records placed at specific dental clinic locations with real-time inventory visibility
Clinic Supply
Live consignment dashboard with low-stock alerts and backorder visibility — no rep calls needed
Dentist / Surgeon
UDI barcode scan auto-populates lot/serial; implant record on blockchain within seconds of placement
Regulatory Authority
Query any lot → instant patient list with tooth location, procedure date, serial number → CSV export
FDA / Regulatory Authority
Register dental devices with full FDA UDI-DI identifiers. Issue and manage 510(k) and PMA clearances. Issue and revoke ISO 13485 manufacturing certificates. Initiate Class I/II/III recalls with immediate effect across the entire network.
Manufacturer
Create production lot records linked to a valid FDA clearance and ISO 13485 certificate — both validated by the smart contract before any lot can be created. QC release lots and flag backorders with estimated resupply dates visible immediately to all downstream participants.
Distributor / Device Rep
Create consignment records placing specific lots at specific dental clinic locations. Real-time inventory usage visibility across all accounts. Instant billing trigger when a device is placed — no more manual reconciliation.
Clinic Supply Chain
Real-time consignment inventory view across all clinic locations. Automatic low-stock alerts below 20%. Backorder and recall alerts — all without calling a rep or counting trays.
Dentist / Oral Surgeon
Fast UDI scan interface — point a Bluetooth barcode scanner at device packaging, lot and serial number auto-populate. Add patient ID, procedure type, tooth number, and jaw location. Complete placement record on the blockchain within seconds.
Infection Control / Risk Management
Enter a lot number and instantly see every patient with a device from that lot placed — patient ID, clinic, procedure, tooth location, date, serial number. Export to CSV for immediate notification. What takes days today takes one second.
UDI compliance built in
Every device registered with its FDA UDI-DI. Every lot captures the Production Identifier (PI) — lot number, serial number, manufacture date, expiry date. The GS1 UDI standard the FDA mandates, read and recorded automatically.
Consignment model support
Built around how the dental device industry actually works — rep-owned inventory on consignment at clinics. Tracks ownership, location, and usage of consigned inventory in real time.
Dual-gate compliance enforcement
A lot cannot be created unless the manufacturer has both a valid FDA clearance for that device AND a valid ISO 13485 certificate. Enforced in the smart contract — cannot be bypassed by the UI or the API.
EPCIS 2.0 event chain
Every supply chain event recorded in GS1 EPCIS 2.0 format. Commission → Quality Release → Consign → Place → Explant → Recall. Complete, auditable, tamper-proof.
Explant & failure tracking
When an implant is removed — osseointegration failure, infection, recall, fracture — the explant event is recorded with reason and device disposition. Critical for post-market surveillance and FDA Medical Device Reports (MDR).
Tamper-proof audit trail
Every transaction cryptographically signed with the identity of the person who performed it. Records cannot be altered, backdated, or deleted — essential in dental malpractice and device liability cases.
Device registration, lot tracking, consignment model, placement/explant recording, recall management, public verification.
Full FDA UDI support, ISO 13485 tracking, EPCIS 2.0 events, infection control recall query, dentist scan interface, supply chain inventory dashboard, cloud deployment.
Multi-organisation Fabric network (separate peers per clinic/manufacturer), Dentrix/Eaglesoft integration, 21 CFR Part 11 validation, pseudonymous patient IDs (HIPAA), monitoring and alerting.
Mobile app for chairside scanning, manufacturer ERP integration (SAP/Oracle), FDA MedWatch adverse event reporting, post-market surveillance analytics, osseointegration outcome tracking.
Want to see DentalChain in action? We run guided walkthroughs tailored to your organisation — access to a live environment is provided on request.
Request a DemoPre-loaded with real devices from the FDA Global Unique Device Identification Database (GUDID)