510(k) K253282
- Device
- ZSmile System
- Applicant
- Dror Orthodesign , Ltd.
- 510(k) number
- K253282
- Product code
- NXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-03
- Date received
- 2025-09-29
- Regulation
- 872.5470
- Classification name
- Aligner, Sequential
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Orly Maor
- Address
- 3 Shatner St. Jerusalem IL 9546103 9546103
FDA Registration Numbers#
- 3025237243
- 3015549533
- 1410097
- 1054415
- 3017619720
- 1420052
- 3017138012
- 3033492726
- 3005663102
- 1420089
- 3028340833
- 3035484470
- 3014749460
- 3035691085
- 3016998377
- 3009482106
- 3015179606
- 2082148
- 3003402534
- 3014054179
- 3006430881
- 2081322
- 1928237
- 3002706372
- 3015143007
- 3010022489
- 3018126402
- 1937100
- 3015302693
- 3011429437
- 3004884150
- 3015342395
- 3015272949
- 1815540
- 1000118628
- 3008475975
- 3007031098
- 1649995
- 1036212
- 3032027578
- 3011221537
- 3017220679
- 3015674959
- 3013508670
- 3032519286
- 3007527669
- 3017155477
- 3004086183
- 3024828760
- 3032193293
- 3016237718
- 1032227
- 3015341209
- 3013551048
- 3033508190
- 2184045
- 3012138716
- 3033273840
- 3017210293
- 3004158247
- 2953749
- 3027500898
- 3015595297
- 1316408
- 3044462786
- 3005695824
- 3042641209
- 3007060769
- 3021024355
- 3014680794
- 3010730876
- 3008261720
- 3009157552
- 3003622434
- 3013556527
- 3022727952
- 3007130440
- 3004793856
- 9680845
Source Documents#
Other 510(k) Records For Product Code NXC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260788 | Smylio Aligners | Smylio, Inc. | 2026-05-08 |
| K260722 | SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. | 2026-04-15 |
| K251454 | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited | 2026-01-07 |
| K250739 | Primeprint Direct Aligner | Dreve Dentamid GmbH | 2025-11-07 |
| K252931 | Invisalign® Palatal Expander System | Align Technology, Inc. | 2025-10-23 |
| K252870 | Invisalign Specifix Attachment System | Align Technology, Inc. | 2025-10-09 |
| K251758 | Serafin® | Tns Co., Ltd. | 2025-09-11 |
| K252380 | Invisalign System | Align Technology, Inc. | 2025-08-29 |
| K251415 | Additively Manufactured Aligner Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-08-27 |
| K251616 | Clear Miracle | Ods Co., Ltd. | 2025-07-22 |
| K242637 | MEM Clear Aligner System | Mem Dental Technology Co., Ltd. | 2025-05-21 |
| K250343 | LuxCreo Clear Aligner System | LuxCreo, Inc. | 2025-04-08 |
| K250487 | SparkTM Clear Aligner System | Ormco Corporation | 2025-02-20 |
| K242715 | Pearl Clear Aligner | Pearl Digital, Inc. | 2025-01-16 |
| K242929 | Fas Aligner System | Xplora 3D Europe S.L | 2024-12-20 |