Byte Aligner System— 510(k) K230199
Substantially EquivalentDentsply Sirona, Inc.
FDA 510(k) clearance K230199 for Byte Aligner System, Substantially Equivalent on 2023-10-18. Applicant: Dentsply Sirona, Inc.. Device class: 2.
Clearance details
- Applicant
- Dentsply Sirona, Inc.
- Product code
- Code NXC
- Device class
- Class 2
- Regulation
- 21 CFR 872.5470
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- York, PA, US
Recent devices under product code NXC
view allMore clearances from Dentsply Sirona, Inc.
view allAdverse events under product code NXC
product code NXC- Injury
- 15,206
- Malfunction
- 2,576
- Other
- 9
- Total
- 17,791
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 K230199
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230199.
Data sourced from openFDA. This site is unofficial and independent of the FDA.