01Who these terms are between
These terms govern the supply of surgical guide design and manufacturing services by
DENTAL WELLNESS, trading as Digital Dental Guides, 63 Vasilissis Sofias Avenue,
Athens 11521, Greece, to a dental practitioner or dental practice acting in the course of their
profession.
This is a business-to-business service. We do not contract with patients, and we do not accept
cases directly from members of the public.
02What we do, and what we do not do
We design and manufacture custom-made surgical templates to the prescription of the treating
clinician, and we prepare the digital plan those templates are built from.
We do not diagnose, we do not decide the indication, and we do not treat your patient. The
clinical decision — whether to place an implant, where, of what dimension, and whether the
plan we propose is appropriate for the person in the chair — is yours alone, and it remains
yours after you approve the plan. Where we believe a different approach would serve the case
better, we say so and explain why; whether to accept it is your call.
03The laboratory
The templates are designed and manufactured in our own laboratory in Athens. The laboratory is
certified for the production of dental prosthetic work and surgical guides in accordance with the
applicable European requirements — we do not outsource the manufacture of your case to a
third-party print bureau.
04Regulatory status of the templates
A template made to your written prescription for one identified patient is a
custom-made device within the meaning of Article 2(3) of Regulation (EU)
2017/745 (the Medical Device Regulation). Custom-made devices are not CE-marked in the way that
series-produced devices are. Instead each device is supplied with the statement required by
Annex XIII of that Regulation, identifying the device, the manufacturer, the prescribing
practitioner and the patient by name or code, and confirming the device’s intended
characteristics.
We retain the associated documentation for the period the Regulation requires, and we operate
the post-market surveillance and vigilance duties that fall on the manufacturer of a custom-made
device.
05Your prescription and your data
To manufacture, we need a prescription from you. In practice that means the case data listed
in the workflow together with your therapeutic objective: what you
intend to achieve, on which teeth or sites, with which implant system and which guided kit, and
any anatomical constraint you already know about.
You confirm, by sending a case, that you are qualified to prescribe it, that you have the
patient’s informed consent to the treatment, and that you are entitled to share the data with us.
How that data is handled is set out in
Patient Data & Case Files.
06Approval before manufacture
Nothing is printed until you have approved the plan in writing, by digital signature on the
approval document. That approval is what converts the plan into a manufacturing instruction.
Please review the plan properly rather than approving it by reflex. Once approved, the plan
is the specification we build to, and a change requested after approval is a new revision with
its own timeline.
07Turnaround and delivery
Cases planned in SMOP or R2GATE are returned to you for review within 48 hours of our
receiving complete, usable data. Incomplete files, or a volume that breaks the
CBCT acquisition rules, pause that clock until the missing part arrives.
Manufacture and delivery run to three to five working days within Greece. Outside Greece,
manufacture takes the same time and the courier’s transit to your country is added; we quote it
before shipping. All delivery times are counted from the date you confirm the plan,
not from the date you first sent the case.
These are the times we work to in normal conditions. They are not guarantees against courier
delay, customs, public holidays or force majeure.
08Fit, revisions and remakes
If a template does not seat as designed and the cause lies with our design or manufacture, we
remake it at our cost and prioritise it. Tell us before the surgery date if you can.
Where the cause lies in the source data — a distorted volume, a scan taken in occlusion,
an intraoral scan that does not match the mouth, an undisclosed change in the dentition between
scan and surgery — a remake is a new case. We will tell you plainly which of the two we
think it is, and show you the data that led us there.
09Materials
Surgical templates are printed in KeyPrint KeyGuide (Keystone Industries), a
resin certified for medical and dental use and intended specifically for surgical guides. We do
not print templates in general-purpose, engineering or model resin, and we do not substitute a
material without telling you.
Post-processing is ours, not yours. Every guide is washed in isopropyl alcohol (97%+), dried,
and fully post-cured in a validated curing unit before it is packed. The protocol sheet in the box
names the material and repeats the sterilisation parameters, so both are identifiable in your own
patient record.
10Sterilisation is done by the clinic
Templates are supplied clean, post-cured, but NOT sterile. That is deliberate
and normal for custom-made surgical templates. Sterilising the guide before the procedure is the
responsibility of the treating clinic, and it must be done before every surgery without
exception.
KeyGuide has a manufacturer-validated steam sterilisation protocol. Follow it:
- Clean. Remove any visible soil from the surface, paying attention to edges
and hollows. Alcohol may be used to wipe the guide down. - Dry. Dry thoroughly, especially inside hollows and drill channels.
Compressed air is effective. - Inspect. Check for cracks or damage once dry. Do not operate with a damaged
template — call us. - Pouch. Use a sterilisation pouch compliant with EN ISO 11607 / ANSI AAMI
ST79, rated to at least 137 °C, with a smooth seal free of wrinkles and folds. - Autoclave, prevacuum cycle, 4 preconditioning pulses.
Europe: 134 °C for 3 minutes, 30 minutes drying.
United States: 132 °C for 4 minutes, 30 minutes drying.
- Load the pouches on edge in the chamber, so that condensate drains rather
than pooling on the device. - Check the seating after sterilisation and before the incision. The template
should seat exactly as it did on the model. If it rocks or lifts, stop and call us.
Do not exceed these parameters and do not improvise a longer or hotter cycle. Resin distorts
with heat, and a template that has changed shape no longer matches the plan it was built from
— while looking perfectly normal. If you are unsure which cycle applies to a particular
guide, ask us before you sterilise rather than after.
11Single patient, single use
Every template is designed against one patient’s anatomy and one approved plan. It is a
single-patient device. It must not be used on another patient, and it should not be re-used for a
second procedure on the same patient unless we designed it as part of a stacked protocol intended
to be used in sequence.
Repeated sterilisation cycles degrade the resin and the sleeve seats. If a case needs a second
stage, tell us at planning time and we will build for it.
12Prices, invoicing and payment
Prices are quoted per case before work begins and confirmed in writing. Where you are a
VAT-registered business in another EU member state, the reverse-charge mechanism applies and
Greek VAT is not charged. Customs duties or import charges outside the EU are yours.
Invoices are payable to the terms stated on them. We may hold delivery of a template on an
unpaid account, but we will never withhold a plan for a case already in surgery without telling
you first.
13Intellectual property
The patient’s data is yours and your patient’s. The plan we produce and the template geometry
we design remain our work product, and we license them to you for the treatment of that patient.
You may keep, archive and share the plan for that patient’s care without asking us.
You may not resell our designs, pass them to another laboratory for reproduction, or use our
name, logo or case material in your own marketing without written permission — which we
usually give, and give gladly, when asked.
14Liability
We are liable for our own work: the accuracy of the design against the approved plan and the
quality of the manufacture. We are not liable for the clinical outcome of the treatment, which
depends on your diagnosis, your technique, the anatomy and the patient.
Nothing in these terms limits liability for death or personal injury caused by our negligence,
for fraud, or for anything else that cannot lawfully be limited — and nothing here affects
your obligations, or ours, under the Medical Device Regulation.
15Reporting a problem
If a template is involved in an incident that harmed, or could have harmed, a patient, tell us
immediately at info@digitalguides.eu and by telephone.
As the manufacturer of the device we have reporting duties under the Medical Device Regulation
that depend on hearing from you, and we would rather investigate ten non-events than miss one
real one.
16Governing law
These terms are governed by Greek law, and the courts of Athens have jurisdiction. If you are
established elsewhere in the EU and would prefer a different forum, raise it before we start
work rather than after a dispute.