Definition: The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
| Device Type ID | 1360 |
| Device Name | Aligner, Sequential |
| Physical State | Device Is Composed Of A Thermoplastic Resin. It May Also Be Accompanied By Software And/or Hardware For Patient Scanning. |
| Technical Method | Digital Scans Of Patient's Dentition Are Used To Create A Series Of Plastic Appliances Which Are Intented To Progressively Move Teeth. |
| Target Area | The Teeth |
| Regulation Description | Orthodontic Plastic Bracket. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.5470 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NXC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
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| Device Type ID | 1360 |
| Device | Aligner, Sequential |
| Product Code | NXC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Orthodontic Plastic Bracket. |
| CFR Regulation Number | 872.5470 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3M COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
3M COMPANY, 3M HEALTH CARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALIGN TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DERBY DENTAL LABORATORY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ECLEAR INTERNATIONAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHO CAPS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECIALTY APPLIANCE WORKS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYBRON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 151 |
Patient-Device Incompatibility | 6 |
Device Operates Differently Than Expected | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Structural Problem | 2 |
Unexpected Therapeutic Results | 2 |
Defective Device | 2 |
Insufficient Information | 2 |
Collapse | 1 |
Malposition Of Device | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Unintended Movement | 1 |
Device Handling Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Appears To Trigger Rejection | 1 |
Material Frayed | 1 |
| Total Device Problems | 181 |