Invisalign System With Mandibular Advancement Featuring Occlusal Blocks (Maob)
The Invisalign System with Mandibular Advancement Featuring Occlusal Blocks uses customized removable aligners to treat dental and skeletal malocclusion. Its mandibular advancement features…
The Invisalign System with Mandibular Advancement Featuring Occlusal Blocks uses customized removable aligners to treat dental and skeletal malocclusion. Its mandibular advancement features are intended for patients with mixed or permanent dentition and address Class I and Class II malocclusions.
A prescribed sequence of thin clear plastic aligners moves teeth in small increments. Occlusal blocks add a mandibular advancement feature intended to produce skeletal changes. Treatment planning software uses the practitioner’s prescription and dental scans to create a plan that the practitioner reviews and approves before manufacture.
Listed Item
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) is used to introduce mandibular skeletal changes in the treatment of Class I and Class II malocclusion, severe open bite, severe overjet, deep bite, skeletally narrow jaw, and those who require surgical correction.
Attachment Templates
When prescribed, disposable polyurethane templates position dental composite attachments on the teeth. Wells in each template guide composite placement. The resulting attachments help retain the aligners or shape the forces used to move teeth.
Who Else Makes It
Concentrated in Guangdong (4), Zhejiang (2), Jiangsu (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Envista (Suzhou) Medical Device Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Envista (Sichuan) Medical Device Co., Ltd. | Ziyang | Sichuan | Contract manufacturer | 4 |
| Sichuan Yinli Medical Equipment Co., Ltd. | Ziyang | Sichuan | Contract manufacturer | 1 |
| Xi’an Henghui Technology, Ltd | Xi’An | Shaanxi | Contract manufacturer | 1 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Royal Dental Lab | Shenzhen | Guangdong | Manufacturer | 12 |
| Wuxi EA Medical Instruments Technologies Limited | Wuxi | Jiangsu | Repacker / relabeller | 6 |
| Shanghai Smartee Denti-Technology Co., Ltd. | Shanghai | Shanghai | Exporter | 5 |
Showing 12 of 14. All 14 manufacturers in China registered for Aligner, Sequential
Record
| Listed by | Align Technology, Inc., United States |
|---|---|
| FDA product code | NXC |
| Device type | Aligner, Sequential |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K232233 |
| Record published | 2024-05-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 221572 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SLX® Clear Aligners | Ortho Organizers, Inc. | 176 |
| Reveal® Aligners | Ortho Organizers, Inc. | 149 |
| Reveal® Clear Aligners | Ortho Organizers, Inc. | 148 |
| ClearArc Aligners | Ortho Organizers, Inc. | 148 |
| Risas Reveal® Aligners | Ortho Organizers, Inc. | 140 |
| Absolute® Clear Aligners | Ortho Organizers, Inc. | 65 |
| 3M™ Clarity™ | 3M Unitek | 56 |
| Reveal™ Aligners | Henry Schein, Inc. | 52 |
| Clear Image Aligner | Specialty Appliances, LLC | 35 |
| Spark | Ormco Corporation | 16 |
| Clarity™ Aligners | 3M Unitek | 14 |
| Clarity™ | Solventum Orthodontics Corporation | 13 |
Showing 12 of 232. All products under Aligner, Sequential
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252931 | 2025-10-23 |
| K252870 | 2025-10-09 |
| K252380 | 2025-08-29 |
| K241412 | 2024-06-18 |
| K232887 | 2023-12-15 |
| K232233 | 2023-09-26 |
| K222894 | 2022-12-22 |
| K220287 | 2022-04-07 |
| K181739 | 2018-10-26 |
| K143630 | 2015-11-18 |
| K081960 | 2008-12-17 |
| K981095 | 1998-09-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.