SureSmile Software
FDA 510(k) K253565 · Dentsply Sirona, Inc.
510(k) numberK253565
Submission
- Device name
- SureSmile Software
- Applicant
- Dentsply Sirona, Inc.
York, PA, US - Received
- November 17, 2025
- Decision date
- March 4, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PNN – Orthodontic Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5470
- Specialty
- Dental
The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.
Other 510(k)s with product code PNN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260419 | LingOral Dental Design SystemPNN · Traditional | Hangzhou ChohoTech Co., Ltd. | 05/08/2026SE |
| K252507 | SmileInspectorPNN · Traditional | Amv Consulting, LLC | 01/07/2026SE |
| K253343 | Celebrace SoftwarePNN · Traditional | Celebrace | 12/29/2025SE |
| K250198 | Laon OrthoPNN · Traditional | Laon Medi, Inc. | 04/23/2025SE |
| K241153 | Progressive Orthodontics AppPNN · Traditional | Progressive Aligners, Inc. | 10/11/2024SE |
| K233625 | Raydent SWPNN · Traditional | Ray Co., Ltd. | 05/16/2024SE |
| K232564 | Align StudioPNN · Traditional | Laon Medi, Inc. | 03/12/2024SE |
| K233616 | Clevaligner Software (V1.0.0)PNN · Traditional | Clevaligner, Ltd. | 01/11/2024SE |
| K232549 | NemoCastPNN · Traditional | Software Nemotec S.L. | 11/21/2023SE |
| K232429 | Titan Dental DesignPNN · Traditional | Clearadvance, LLC | 10/13/2023SE |
More from Clearadvance, LLC
| 510(k) | Device | Decision |
|---|---|---|
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| K260785 | DS Core CBCT AnatomyQIH · Traditional | 04/23/2026SE |
| K260722 | SureSmile Aligner (ASSY500020)NXC · Traditional | 04/15/2026SE |
| K251614 | Stainless Steel Surgical KitsKCT · Traditional | 02/06/2026SE |
| K253959 | Primevision 3DOAS · Traditional | 02/05/2026SE |
| K253009 | DS Core DetectMYN · Traditional | 01/07/2026SE |
| K252343 | Atlantis® Abutments in TitaniumNHA · Traditional | 12/09/2025SE |
| K252248 | CEREC Tessera Abutment SystemNHA · Traditional | 11/26/2025SE |
| K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsNHA · Traditional | 11/21/2025SE |
Questions and answers
When was SureSmile Software cleared by the FDA?
SureSmile Software (K253565) received a 510(k) decision of Substantially Equivalent on March 4, 2026, 107 days after the submission was received.
What is the product code of K253565?
The FDA product code is PNN – Orthodontic Software, a Class II (moderate risk) device regulated under 21 CFR 872.5470.