Aligner, sequential: medical device reports filed with FDA

18,532 reports carry this product code, 2006–2026; 9 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

18,532
reports with this product code: 0.1% of all MAUDE reports; 2,863
reports, 12 months to August 2026: 12,078 in the 12 months before; 14%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code NXC is FDA's classification for "Aligner, sequential" (dental panel), a class 2 device. 18,532 medical device reports carry this product code, 0.1% of the MAUDE database, from May 2006 to August 2026.

2,863 reports arrived in the 12 months to August 2026, down 76% from 12,078 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (85.4%), malfunction (14%) and other (0.5%). 9 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Byte Day Aligners	6,934	1,360	0%	19.8%
Byte Night Aligners	6,802	1,202	0%	12.2%
Smiledirectclub Aligner System	1,527	0	0.1%	0.1%
Byte Day Aligner	727	0	0%	22.3%
Byte Night Aligner	711	0	0%	15.9%
Invisalign System	520	0	0%	0%
Nontemplate Aligner Arch	188	55	0%	25.5%
Invisalign System - Comprehensive	181	122	0%	0%
Byte Retainer	70	830	0%	8.6%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Straight Smile	15,411	83.2%
Access Dental Lab	1,559	8.4%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0%1

Injury85.4%15,835

Malfunction14%2,600

Other0.5%90

Not given0%6

Who filed

Manufacturer report98%18,160

Voluntary report2%372

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Patient-device incompatibilitythe device did not suit the patient	10,022	54.1%
Sharp edges	4,476	24.2%
Device appears to trigger rejection	2,126	11.5%
Defective devicethe device was defective	1,680	9.1%
Inadequacy of device shape and/or size	1,163	6.3%
Lack of effect	419	2.3%
Structural problem	418	2.3%
Unintended movement	384	2.1%
Insufficient device problem information	231	1.2%
Patient device interaction problem	157	0.8%
Crackthe device cracked	67	0.4%
Breakthe device broke	56	0.3%
Pressure problem	44	0.2%
Fitting problem	40	0.2%
Biocompatibility	21	0.1%
Therapeutic or diagnostic output failure	19	0.1%
Improper or incorrect procedure or method	17	0.1%
Unexpected therapeutic results	14	0.1%
Device operates differently than expectedthe device behaved unexpectedly	12	0.1%
Failure to align	11	0.1%

Questions about aligner, sequential reports

What is product code NXC?

FDA's classification code for "Aligner, sequential", class 2, reviewed by the dental panel. Every device report carries the product code of the device involved.

How many reports carry this code?

18,532 reports through August 2026, 2,863 of them in the latest 12 months.

Which brands appear most often?

Byte Day Aligners (6,934), Byte Night Aligners (6,802), Smiledirectclub Aligner System (1,527), Byte Day Aligner (727) and Byte Night Aligner (711). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.