Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NXC · Predicate Candidate Screening
145 FDA 510(k) clearances under this product code; the 50 most recent screened below.
128 daysmedian FDA review time
313 days90th percentile
145clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260527 | FACE4D Aligner | Avinent Implant System S.L.U. | 2026-07-02 | 135 | 0 |
| K260788 | Smylio Aligners | Smylio, Inc. | 2026-05-08 | 59 | 0 |
| K260722 | SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. | 2026-04-15 | 41 | 0 |
| K253282 | ZSmile System | Dror Orthodesign , Ltd. | 2026-02-03 | 127 | 0 |
| K251454 | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited | 2026-01-07 | 240 | 0 |
| K250739 | Primeprint Direct Aligner | Dreve Dentamid GmbH | 2025-11-07 | 241 | 0 |
| K252931 | Invisalign® Palatal Expander System | Align Technology, Inc. | 2025-10-23 | 38 | 0 |
| K252870 | Invisalign Specifix Attachment System | Align Technology, Inc. | 2025-10-09 | 30 | 0 |
| K251758 | Serafin® | Tns Co., Ltd. | 2025-09-11 | 94 | 0 |
| K252380 | Invisalign System | Align Technology, Inc. | 2025-08-29 | 30 | 0 |
| K251415 | Additively Manufactured Aligner Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-08-27 | 112 | 0 |
| K251616 | Clear Miracle | Ods Co., Ltd. | 2025-07-22 | 56 | 0 |
| K242637 | MEM Clear Aligner System | Mem Dental Technology Co., Ltd. | 2025-05-21 | 260 | 0 |
| K250343 | LuxCreo Clear Aligner System | LuxCreo, Inc. | 2025-04-08 | 61 | 0 |
| K250487 | SparkTM Clear Aligner System | Ormco Corporation | 2025-02-20 | 1 | 0 |
| K242715 | Pearl Clear Aligner | Pearl Digital, Inc. | 2025-01-16 | 128 | 0 |
| K242929 | Fas Aligner System | Xplora 3D Europe S.L | 2024-12-20 | 87 | 0 |
| K242892 | Cristaline Aligners Z FLX | Cristaline Aligners GmbH | 2024-12-19 | 87 | 0 |
| K233152 | GENIOVA aligners | Geniova Technologies Sociedad Limitada | 2024-12-12 | 442 | 0 |
| K240501 | Spark™ Clear Aligner System | Ormco Corporation | 2024-10-11 | 233 | 0 |
| K233356 | Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. | 2024-08-08 | 314 | 0 |
| K241137 | Clear Moves Aligner | Clear Moves Aligners | 2024-08-01 | 99 | 0 |
| K241187 | Alien Aligners | Alien Milling Technologies | 2024-07-26 | 88 | 0 |
| K241412 | Invisalign System | Align Technology, Inc. | 2024-06-18 | 32 | 0 |
| K233935 | DigiLine Direct Print Aligner System | Park Dental Research Corporation | 2024-04-05 | 113 | 0 |
| K240038 | Clear Moves Aligners | Space Maintainers Laboratories (Sml) | 2024-04-04 | 90 | 0 |
| K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky | Blue Sky Bio, LLC | 2024-04-03 | 216 | 0 |
| K240597 | TERA HARZ CLEAR | Graphy, Inc. | 2024-03-05 | 1 | 0 |
| K233544 | MESHEET | Dentis Co., Ltd. | 2024-02-22 | 111 | 0 |
| K232074 | Serafin® | Tns Co., Ltd. | 2024-02-22 | 225 | 0 |
| K232887 | Invisalign Palatal Expander System | Align Technology, Inc. | 2023-12-15 | 88 | 0 |
| K230199 | Byte Aligner System | Dentsply Sirona, Inc. | 2023-10-18 | 266 | 1 |
| K233257 | 3M™ Clarity™Aligners with Quick Attachments | 3M Company, Unitek Orthodontic Products | 2023-09-29 | 1 | 1 |
| K232233 | Invisalign System with Mandibular Advancement Featuring Occl | Align Technology, Inc. | 2023-09-26 | 61 | 0 |
| K231884 | TRIOCLEAR System | Modern Dental Laboratory (Dg) Co., Ltd. | 2023-09-01 | 66 | 0 |
| K223517 | Clear Aligner | Wuxi EA Medical Instruments Technologies Limited. | 2023-06-13 | 202 | 0 |
| K231464 | 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clar | 3M Company, Unitek Orthodontic Products | 2023-05-22 | 3 | 0 |
| K223141 | STR8 Clear Aligner | Str8 Oral Care | 2023-04-24 | 202 | 0 |
| K223454 | Custom-made Invisible Aligners | Zhejiang Yinchili Medical Technology Co., Ltd. | 2023-04-17 | 152 | 0 |
| K221537 | Nightwear Aligners | Smylio, Inc. | 2023-04-05 | 313 | 0 |
| K222619 | Ensmile | Ensmile Pvt, Ltd. | 2023-03-16 | 198 | 0 |
| K221845 | Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio | Blue Sky Bio, LLC | 2023-02-24 | 245 | 0 |
| K223338 | Toothsi, Smilealigners | Makeo Healthcare Technologies Private Limited | 2023-02-09 | 100 | 0 |
| K222894 | Invisalign System, Pre-Formed Attachment System | Align Technology, Inc. | 2022-12-22 | 90 | 0 |
| K222308 | Al Smile Aligner | Nanjing Jiahe Dental Technology Co., Ltd. | 2022-12-20 | 141 | 0 |
| K222918 | DentCare Aligners | Dentcare Dental Lab Pvt , Ltd. | 2022-11-25 | 60 | 0 |
| K223355 | Tera Harz Clear | Graphy, Inc. | 2022-11-03 | 1 | 0 |
| K211427 | CREOKORREKT Aligners | Creodent Prosthetics, Ltd. | 2022-10-13 | 524 | 0 |
| K222418 | Nuvola | Gruppo Europeo Ortodonzia Srl | 2022-10-07 | 58 | 0 |
| K220140 | ClearCorrect System | Clearcorrect, LLC | 2022-10-05 | 260 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda