Dentsply Sirona: FDA clearances and approvals
Dentsply Sirona has 88 FDA 510(k) clearances (first 2016, latest 2026), across 26 product codes in 5 review panels. Median 510(k) review time: 126 days. Since 2017 its median was 124 days, against 136 days for all cleared 510(k)s in the same product codes. It files with the SEC as DENTSPLY SIRONA Inc. (XRAY).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 7 | 135 |
| 2017 | 10 | 124 |
| 2018 | 8 | 109 |
| 2019 | 9 | 124 |
| 2020 | 11 | 141 |
| 2021 | 5 | 96 |
| 2022 | 6 | 221 |
| 2023 | 4 | 204 |
| 2024 | 8 | 114 |
| 2025 | 12 | 90 |
| 2026 | 8 | 72 |
Review time against the same product codes
Since 2017, Dentsply Sirona's cleared 510(k)s took a median 124 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 23 | 23 |
| DZE | Implant, Endosseous, Root-Form | 9 | 9 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 6 | 6 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 6 | 6 |
| EIH | Powder, Porcelain | 5 | 5 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
| NDP | Accessories, Implant, Dental, Endosseous | 3 | 3 |
| NXC | Aligner, Sequential | 3 | 3 |
| OAS | X-Ray, Tomography, Computed, Dental | 3 | 3 |
| QIH | Automated Radiological Image Processing Software | 3 | 3 |
Plus 16 more product codes.
Review panels
- Dental (66)
- Radiology (10)
- General Hospital (6)
- Gastroenterology and Urology (4)
- General and Plastic Surgery (2)
Most recent Dentsply Sirona 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261935 | Surgical and Prosthetic Trays | KCT | 2026-09-04 | 87 |
| K262127 | DS Core CBCT Anatomy | QIH | 2026-08-21 | 58 |
| K260785 | DS Core CBCT Anatomy | QIH | 2026-04-23 | 44 |
| K260722 | SureSmile Aligner (ASSY500020) | NXC | 2026-04-15 | 41 |
| K253565 | SureSmile Software | PNN | 2026-03-04 | 107 |
| K251614 | Stainless Steel Surgical Kits | KCT | 2026-02-06 | 255 |
| K253959 | Primevision 3D | OAS | 2026-02-05 | 57 |
| K253009 | DS Core Detect | MYN | 2026-01-07 | 110 |
| K252343 | Atlantis® Abutments in Titanium | NHA | 2025-12-09 | 134 |
| K252248 | CEREC Tessera Abutment System | NHA | 2025-11-26 | 131 |
78 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dentsply Sirona.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
SEC filings
DENTSPLY SIRONA Inc. (XRAY): EDGAR filings, CIK 818479. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Dentsply Sirona have?
Dentsply Sirona has 88 FDA 510(k) clearances (first 2016, latest 2026), across 26 product codes in 5 review panels.
How long does FDA take to clear Dentsply Sirona's 510(k)s?
The median time from FDA receipt to decision across Dentsply Sirona's cleared 510(k)s is 126 days. Since 2017: 124 days, versus 136 days for all cleared 510(k)s in the same product codes.
What devices does Dentsply Sirona make?
Its most frequent FDA product codes are NHA (Abutment, Implant, Dental, Endosseous, 23); DZE (Implant, Endosseous, Root-Form, 9); EBI (Resin, Denture, Relining, Repairing, Rebasing, 6).
Has Dentsply Sirona had device recalls?
openFDA lists no recalls under a recalling firm name matching Dentsply Sirona. Related entities may recall under other names.
Next steps
- See all 88 Dentsply Sirona clearances with predicates and recalls
- Run predicate analysis for product code NHA, Dentsply Sirona's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.