Nobel Biocare AB · Class II · Cleared Feb 18, 2026
| K-number | K252197 |
| Device name | Nobel Biocare S Series Implants |
| Applicant | Nobel Biocare AB |
| Product code | DZE |
| Device class | Class II |
| Decision date | Feb 18, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.3640 |
The Nobel Biocare S Series Implants are endosseous dental implants made of commercially pure titanium, intended to be surgically placed in the upper or lower jaw bone to anchor or support tooth replacements and restore chewing function and esthetics. The system comprises six device lines (NobelActive S, NobelParallel S, and NobelReplace S, each available in TiUltra or TiUnite surface variants) available in multiple diameters and lengths for single or multiple unit restorations using 2-stage or 1-stage surgical techniques with various loading protocols.
The subject devices feature a consistent Narrow Platform (NP) conical connection across all implant diameters and types, whereas the predicate devices use NP only for smaller diameters (3.5–3.75 mm) and larger RP or WP connections for bigger implants. This design introduces increased platform shift (0.295–1.275 mm across variants) compared to predicate. The implant bodies, macro design (tapered with backtapered coronal design or parallel geometry), material, surface treatment (anodic oxidation), sterilization (gamma, SAL 10⁻⁶), and packaging are identical or equivalent to the predicate.
ISO 14801 (dynamic loading of endosseous implants), ISO 10993-1 (biocompatibility), ISO 11607-1:2019 and ISO 11137 series (sterilization validation and radiation sterilization dose), ASTM D4169 (packaging performance), ASTM F2052, F2213, F2119, and F2182 (MR safety testing), USP 42-NF37:2019 (endotoxin testing), and ANSI/AAMI ST72:2011.
The subject devices are substantially equivalent to the predicate (K202344, TiUltra Implants) because they share identical indications for use, material composition, macro design, surface treatment, sterilization, and biocompatibility. Although the subject devices use a universal NP connection for all diameters (increasing platform shift on larger implants), dynamic fatigue testing demonstrated equivalent or superior performance to the predicate and reference devices. The use of existing prosthetic workflows and components, combined with equivalent nonclinical testing data, establishes substantial equivalence without clinical testing.
View the full FDA submission: accessdata.fda.gov