EU MDR · Annex XIII
Statement for custom-made devices
Issued per case, kept at least 10 years, 15 for implantable devices.
Sample statement · PDFDental laboratory · For dentists and practices only
Send the case once, see every stage.
Kuspis is a dental laboratory working only for dentists and practices. Scan, shade, due date and courier pickup go into one form, and each case is tracked by its code from bench to shipping.
36 · crownBridge 14 · 1611 · layered
- Who we work for
- Dentists and practices only
- Files
- STL, PLY, OBJ
- Identity
- Case code, not patient name
- Paperwork
- Statement with every custom device
01Products and materials
What we make, and from what.
Material, indication, what to send and try-in stages for every product. All lead to the same case form.
01
Zirconia crowns and bridges
- Material
- Monolithic or porcelain layered zirconia
- Indication
- Single crowns, bridges and posterior restorations
- What to send
- Scan or impression, opposing arch, bite record, shade
- Try-in
- None for monolithic; optional framework try-in for layered
At the lab5 working daysSend a case with this product
02
Lithium disilicate (e.max)
- Material
- Glass ceramic, pressed or milled
- Indication
- Anterior crowns, veneers, inlays and onlays
- What to send
- Scan, preparation photo, shade and stump shade
- Try-in
- Optional mock-up try-in
At the lab6 working daysSend a case with this product
03
Implant restorations
- Material
- Titanium or zirconia abutments, screw retained or cemented
- Indication
- Single units, bridges and full arch superstructures
- What to send
- Scan body scan or impression copings, implant system and platform
- Try-in
- Passive fit try-in for bridges and full arches
At the lab8 working daysSend a case with this product
04
Metal ceramic
- Material
- Cobalt chrome framework, milled or laser sintered
- Indication
- Long span bridges and cases where metal is preferred
- What to send
- Impression or scan, shade, bite record
- Try-in
- Framework try-in, then bisque try-in
At the lab7 working daysSend a case with this product
05
Splints and night guards
- Material
- Milled PMMA or hard clear acrylic
- Indication
- Night guards and occlusal splints
- What to send
- Both arches, bite record, requested thickness
- Try-in
- No try-in needed
At the lab4 working daysSend a case with this product
06
Removable prosthetics
- Material
- Acrylic full dentures and cast partials
- Indication
- Complete and partial edentulism
- What to send
- Impressions, bite record, set-up preferences
- Try-in
- Wax try-in and framework try-in
At the labStaged Send a case with this product
02How we work
We work with dentists, never with patients.
- A
Cases from dentists only
Work comes from dentists and practices only; the case form is open to them alone.
- B
No patient contact
We never contact patients. Questions about shade or design go back to the dentist.
- C
A code, not a name
Files and tracking use a case code, and scans are deleted after a set period.
- D
Paperwork with every case
Each custom-made device ships with its statement; a copy stays on file.
03Send a case
One form, one work order.
The work order on the right fills as you go. Nothing gets lost in a phone note.
04Production tracking
Which bench is your case on?
In the dentist portal every case moves through six time stamped stages. The cases below are samples.
Sample cases
Now
Due
Sample- Received
Files and details checked; gaps go back to the dentist.
- Design
Designed digitally, sent for approval on request.
- Milling
Milled from a disc or block.
- Sintering
Zirconia reaches its final strength in the furnace.
- Finishing
Staining, glaze and final inspection.
- Shipped
Packed with the statement, handed to the courier.
05Turnaround and digital impressions
When it comes back, how we take the file.
| Product | At the lab |
|---|---|
| Zirconia crowns and bridges | 5 working days |
| Lithium disilicate (e.max) | 6 working days |
| Implant restorations | 8 working days |
| Metal ceramic | 7 working days |
| Splints and night guards | 4 working days |
| Removable prosthetics | Staged |
Working days from receipt at the lab, try-ins excluded. Sample values.
Digital impression intake
- Formats
- STL, PLY and OBJ
- Scanners
- Intraoral scanners that export to open formats
- Size
- Up to 250 MB per file
- Include
- Case code, tooth numbers, shade, opposing arch and bite record
- Storage
- Assigned technician only; deleted after a set period
Courier rounds on weekday mornings and afternoons; distant impressions by tracked post.
06Documents
The paperwork is part of the work.
Documents that travel with each case or are shared on request. The lab fills in the numbers before launch.
MHRA
MHRA registration
Registration reference: [0000000] for devices placed on the Great Britain market.
PlaceholderGDC
GDC registered technicians
Dental technicians listed with their GDC registration numbers: [000000].
PlaceholderMaterials
Manufacturer certificates
Conformity documents for our zirconia, ceramics and alloys, with lot numbers.
Document archive07FAQ
What dentists ask first.
Can patients contact you directly?
No. We work only for dentists and practices and do not communicate with patients; a patient who reaches us is referred back to their dentist.
Which scanners do you accept files from?
Any intraoral scanner that exports STL, PLY or OBJ. For closed systems we check export settings with you on the first case.
When does the turnaround start?
When files and details reach the lab and pass the received stage. It counts in working days, try-ins are added, and the due date is written on the work order.
Do you work for practices outside Turkey?
Yes. Product and document information is available in English and German, every custom-made device ships with the statement required by Annex XIII of the EU MDR, and shipping is agreed in writing before the first case.
08Contact
Let us talk before the first case.
Ask about how we work, courier coverage or scanner settings. For dentists and practices only.
- Phone
- +90 000 000 00 00
- hello@kuspis.example
- Location
- Ankara, Turkey
- Hours
- Weekdays 08.30 to 18.30