FDA 510(k) cleared material from a TÜV Rheinland ISO 13485 certified manufacturer. Small orders from 5 discs — test on real cases before committing to volume.
Gradient shade is built into every disc, so your technician skips the staining step — roughly 20–30 minutes saved per unit. 98 mm diameter, 10–30 mm thickness.
Full technical data sheet (strength, translucency, shrinkage, sintering curve) available on request. VITA 16 shade range plus BL1–BL4.
Gradient shade is sintered into the disc. Your technician saves roughly 20–30 minutes per unit compared with white zirconia plus hand layering.
FDA 510(k) K181816, cleared July 2018. The manufacturer holds TÜV Rheinland ISO 13485. Both are publicly verifiable — check them yourself.
No container loads. Mixed models and shades in one order, so you can test on real cases before committing to volume.
Single production source. Every disc carries a batch number and its sintering curve, so a problem can be traced to the lot.
We do not ask you to take our word for it. Both certifications below are public records.
K181816Ceramic Denture Zirconia Ceramics Block · Class II · 21 CFR 872.6660 · Cleared 9 July 2018.
Quality management system for medical devices. Certificate SX 2180777-1, valid to 11 September 2028.
Scope: design, development, manufacture and distribution of dental zirconia ceramic.
Tell us which shades and thicknesses you use most and roughly how many units you produce per month. We will confirm sample terms and shipping by reply.