Paragon Implant Mfg., LLC · Class II · Cleared Dec 23, 2025
| K-number | K252145 |
| Device name | GEN5 and GEN5+ 3.3mmD Dental Implants |
| Applicant | Paragon Implant Mfg., LLC |
| Product code | DZE |
| Device class | Class II |
| Decision date | Dec 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.3640 |
The GEN5 and GEN5+ 3.3mm Dental Implants are two-piece endosseous root-form dental implants manufactured from titanium alloy (Ti-6Al-4V ELI) for surgical placement in the upper or lower jaw. They are indicated for single or multiple tooth replacement, denture stabilization, and support of fixed bridgework in partially or fully edentulous patients, with capability for one-stage or two-stage procedures and immediate loading when primary stability is achieved.
The subject device is a 3.3mm diameter, bone-level implant with a 2.0mm straight machined anodized collar featuring horizontal grooves, a tapered body with double-lead buttress threads and two cutting flutes. Key differences from the primary predicate (K192221) include the machined anodized grooved collar (versus the predicate's micro-threaded design), double-lead threads (versus triple-lead), and two cutting flutes (versus three). The anodization and blasting surface treatment are identical to the reference device K251938.
ISO 10993 (biocompatibility), ISO 7405, ASTM F136-13 (titanium alloy specification), ASTM F543 A1/A2/A3 (torsional yield and pullout testing), ISO 14801 (fatigue/dynamic load testing), ASTM F2052/F2119/F2182/F2213 (MRI validation), ASTM F1980-21 (accelerated aging), ASTM D4169 and ASTM F7386 (transportation conditioning), ANSI/AAMI/ISO 11137-2 (sterilization validation), and FDA Class II Special Controls Guidance for dental implants.
The subject device is substantially equivalent to the primary predicate (K192221) because both are threaded root-form titanium implants with similar intended use, internal hex connection, comparable diameters and lengths (9–14mm), same sterilization method (gamma irradiation), and similar blasted surface treatment. Despite design differences in collar machining, thread lead, and cutting flutes, comprehensive performance testing (fatigue, torsional yield, pullout load) demonstrates equivalent functional safety and efficacy, and the anodized collar design is identical to previously cleared reference devices.
View the full FDA submission: accessdata.fda.gov