FDA 510(k) ClearanceDZE
NobelZygoma TiUltra Implant system
FDA 510(k) K243834 · Nobel Biocare AB
- 510(k) number
- K243834
- Device name
- NobelZygoma TiUltra Implant system
- Applicant
- Nobel Biocare AB
- Product code
- DZE
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 872.3640
- Advisory committee
- DE
- Medical specialty
- Dental
Candidate predicate devices
Other devices cleared under product code DZE form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251188 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | |
| K250806 | Dental Implant System | A.B. Dental Devices , Ltd. | |
| K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | |
| K260006 | INOSS System | Inosys, Inc. | |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB | |
| K252031 | Adin Long Dental Implant System | Adin Dental Implant Systems , Ltd. | |
| K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | |
| K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | |
| K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | |
| K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB | |
| K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | |
| K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. |
Building a 510(k) around this device type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.