From idea
to reality.

Bring us anything. Or nothing.

A finished CAD file. A photo of a competitor instrument with a circle drawn around the part you'd change. A clinical brief written by your KOL. A hand-sketch on a Post-it. A vague idea you can describe on a phone call. All of those count as a starting point.

If you've never done private label before — that's fine too. We've helped distributors launch their first house brand, clinic chains build their first co-branded kit, and academic groups create their first student instruments. The blank page is a familiar place for us.

We do the design work. All of it.

This is where most OEM relationships fail — when the brand realises the "OEM" partner expects them to do the engineering. We don't.

Our Danish design team takes your input and turns it into a real instrument. Tip shape, handle ergonomics, weight, finish, materials. We work with our Nordic clinical advisors so the final tool actually performs in a real operatory — not just in a render.

• 3D models and prototypes
• Materials (stainless, tungsten-carbide, titanium, aluminium)
• Coatings (gold non-stick, black, blue, anti-reflective)
• Silicone handles in 15 colours or a custom Pantone
• Clinical try-outs with our advisors

You see the result before anything goes into production. Several iteration rounds are normal — we don't charge for the first refinements.

Class I & I-R, handled correctly.

Most ErgoDenta hand instruments are Class I medical devices under EU-MDR. Reusable surgical instruments fall under Class I-R, which adds a Notified Body review of the reuse and reprocessing aspects. We run that compliance work — you don't.

What you get from us:

• EU-MDR technical documentation appropriate to the device class
• Declaration of Conformity for CE marking
• Product barcodes (UDI) and EU database registration
• User instructions and labelling per EU-MDR Annex I
• Quality system records under ISO 13485
• FDA establishment registration and UKCA documentation where applicable

You handle the local registration in your country with our paperwork in your hand. No solo work in front of a regulator.

Our supply chain becomes yours.

The product you build is yours. The supply chain behind it is already ours.

We've spent years building production capability, raw-material relationships, testing infrastructure, logistics routes, and a Danish warehouse — built and run specifically for ergonomic dental instruments. You step into that infrastructure from day one, regardless of what you're producing.

What flows through it for you is whatever you specify:

• An instrument from your own design or your KOL's brief
• An instrument we don't yet produce
• A category that fits your market but wouldn't fit our catalogue
• A hybrid built from a sketch, a CAD file, or a sample

What you don't do: audit factories, qualify steel suppliers, run incoming QC, manage compliant logistics. We do that work upstream. You get the output, under your brand.

If your concept happens to overlap with something we already produce, lead times can be shorter — existing tooling and quality records save development time. If your concept is new to us, the supply chain still delivers — we add the tooling, validate it, and produce.

Your brand. Your customer. We stay invisible.

Once production starts, the product is yours. Your logo on the handle, your colours on the packaging, your user instructions, your retail box, your catalogue. We never sell to your customer. We never appear on the packaging. We don't market alongside you in your country.

If you want exclusivity — a product, a category, or a region — we sign for it. In the markets where we have an exclusive distributor, we don't open a second one. Quiet, predictable, no surprises.

Re-orders that just work.

The first production run is the hard part. After that, the relationship gets boring — in the best way. Re-orders are usually 4–8 weeks. The stock items go faster. We keep your tooling, your packaging plates, and your specs ready to run.

We don't go quiet between orders. Your named project manager keeps you in the loop on raw-material lead times, regulatory updates that affect your registrations, and new instruments coming into the catalogue that might fit your line.