Aligner, Sequential
Dental · 21 CFR 872.5470
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.
Recent MDR events
18,498 adverse event reports on file
- NONTEMPLATE ALIGNER ARCHJul 31, 2026MalfunctionDentsply Sirona Orthodontics Inc.1649995-2026-00049
- NONTEMPLATE ALIGNER ARCHJul 31, 2026MalfunctionDentsply Sirona Orthodontics Inc.1649995-2026-00050
- Byte Night AlignersJul 31, 2026InjuryStraight Smile Llc3031789024-2026-02836
- Byte Day AlignersJul 31, 2026InjuryStraight Smile Llc3031789024-2026-02833
- NONTEMPLATE ALIGNER ARCHJul 30, 2026MalfunctionDentsply Sirona Orthodontics Inc.1649995-2026-00048
- Byte Night AlignersJul 30, 2026InjuryStraight Smile Llc3031789024-2026-02841
- Byte Day AlignersJul 30, 2026InjuryStraight Smile Llc3031789024-2026-02842
- Invisalign System - ComprehensiveJul 29, 2026InjuryAlign Technology (sichuan) Medical Equipment Co.,2953749-2026-02233
- NONTEMPLATE ALIGNER ARCHJul 28, 2026InjuryDentsply Sirona Orthodontics Inc.1649995-2026-00045
- NONTEMPLATE ALIGNER ARCHJul 28, 2026InjuryDentsply Sirona Orthodontics Inc.1649995-2026-00046
Event type breakdown
Recalls
2 recall events for this product code
- 3M Company - Health Care BusinessOpen, ClassifiedDec 23, 2024
Clarity Precision Grip Attachments, for use in orthodontic treatment.
Attachments may not mate with the tooth as intended in the digital treatment design.
Z-0743-2025 · View FDA record ↗ - Straight Smile, LLCOpen, ClassifiedDec 23, 2024
BYTE Aligner System REF PRS-0063
Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.
Z-0750-2025 · View FDA record ↗
Registered firms
191 firms currently registered for this product code
Ulab Systems, Inc
Memphis, TN, US
Solventum Orthodontics Corporation
Monrovia, CA, US
K Line Egypt
Cairo, EG
Border Assembly S. De R.l De C.v.
Tijuana Baja California, MX
Ortho Solutions Lc
Lake Saint Louis, MO, US
Xplora Usa Llc
Carrollton, TX, US
Align Technology De Costa Rica S.r.l
Belen Heredia, CR
Align Technology, Inc.
San Jose, CA, US
Alta Smiles, Llc
Fort Washington, PA, US
Aligntech De Mexico S, De R. L. De C. V.
Cd. Juarez Chihuahua, MX
Align Technology Afab Poland Sp. Z O.o.
Wroclaw Dolnoslaskie, PL
Sds De Mexico S. De R.l. De C.v.
MEXICALI, B.C. C.P. Baja California, MX
Clearpath Orthodontics
Lahore Punjab, PK
Axiom Marketing, Inc.
Green Oaks, IL, US
Xplora 3d Europe Sl
Madrid Madrid (Province), ES
K Line Florida
West Palm Beach, FL, US
Ningbo Sezen Technology Co., Ltd.
Ningbo Zhejiang, CN
Aso International Manila, Inc.
Cavite,Region IVa,, PH
Allesee Orthodontic Appliances, Inc.
Sturtevant, WI, US
Eh Dental Services Costa Rica Sociedad De Responsabilidad Limitada
Escazu, San Rafael San Jose, CR
Five Star Orthodontic Laboratory & Supply, Inc.
Denton, TX, US
Aligntech De Mexico S, De R. L. De C. V.
Cd. Juarez Chihuahua, MX
Xi'an Henghui Technology, Ltd
Xi'an Shaanxi, CN
Envista (suzhou) Medical Device Co., Ltd.
Suzhou Jiangsu, CN
510(k) clearances
145 clearances for this product code
- Avinent Implant System S.L.U.Jul 2, 2026
K260527 · FACE4D Aligner
- Smylio, Inc.May 8, 2026
K260788 · Smylio Aligners
- Dentsply Sirona, Inc.Apr 15, 2026
K260722 · SureSmile Aligner (ASSY500020)
- Dror Orthodesign , Ltd.Feb 3, 2026
K253282 · ZSmile System
- Beame Medical Technology (Shenzhen) LimitedJan 7, 2026
K251454 · Clear Aligner (SCF-3348)
- Dreve Dentamid GmbHNov 7, 2025
K250739 · Primeprint Direct Aligner
- Align Technology, Inc.Oct 23, 2025
K252931 · Invisalign® Palatal Expander System
- Align Technology, Inc.Oct 9, 2025
K252870 · Invisalign Specifix Attachment System