N1 TiUltra TCC Implant System— 510(k) K211109
Substantially EquivalentNobel Biocare Services AG
FDA 510(k) clearance K211109 for N1 TiUltra TCC Implant System, Substantially Equivalent on 2021-12-21. Applicant: Nobel Biocare Services AG. Device class: 2.
Clearance details
- Applicant
- Nobel Biocare Services AG
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kloten, CH
Recent devices under product code DZE
view allMore clearances from Nobel Biocare Services AG
view allAdverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K211109
K-number listed on FDA's recall record- Z-1101-2025 — . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function
- Z-1565-2022 — Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211109.
Data sourced from openFDA. This site is unofficial and independent of the FDA.