Quality & regulatory

Proof, not claims. What we can show you.

SAMZ is run by engineers. We would rather give you a registration number, a lot number and a signed statement than an adjective. This page sets out exactly what stands behind each case.

Technician applying ceramic to a bridge by hand with a fine brush

MHRA registered40046

MHRARegistered · 40046

ISO 13485Certification in progress

Every unitCarries a lot number

Each caseStatement of Manufacture

Regulatory position

Where SAMZ stands today

MHRA registration: SAMZ Dental Lab is registered with the Medicines and Healthcare products Regulatory Agency.Registration number: 40046
ISO 13485: Certification of our quality management system is in progress.We will publish the certificate here when it is issued, and not before.
Statement of Manufacture: Every case is a custom-made device and is returned with its Statement of Manufacture.It identifies the device, your prescription and the patient reference.
Traceability: Every item carries a lot number that links it to its case, its materials and its quality checks.
Warranty: Remakes for up to 5 years on crown and bridge and up to 2 years on removables.Subject to our warranty terms.

Quality checks

What is checked before a case returns

Each case passes the same sequence of checks, carried out to SAMZ standards.

Incoming case checkImpression or scan quality, prescription complete
Model and die check
Design check
Fit and margins on the model
Contacts and occlusion on the articulator
Shade against the prescribed tab
Final check to SAMZ standardsLot number assigned, Statement of Manufacture issued

Ceramic prosthesis mounted on plaster models in an articulator — Occlusion · checked on the articulator

Accountability

One company accountable for every case.

SAMZ is responsible for each case from collection to delivery: manufacture to your prescription, quality assurance to SAMZ standards, the paperwork and the warranty. If something is not right, you deal with one company.

Materials

Named materials, not generic ones

Material certificates are available on request for any case.

Lithium disilicate: IPS e.max, Ivoclar
Zirconia: Dental Direkt
Casting alloys: BEGO and Argen
Precious alloy certification: Identalloy
Flexible denture base: Valplast
Other materials: Dentsply

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