Definition: An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position.
| Device Type ID | 1339 |
| Device Name | Bracket, Ceramic, Orthodontic |
| 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 | NJM |
| 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 | 1339 |
| Device | Bracket, Ceramic, Orthodontic |
| Product Code | NJM |
| 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 HEALTH CARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AJW TECHNOLOGY CONSULTANTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CDB CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORMCO CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHO ORGANIZERS , INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROGRESSIVE TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYBRON DENTAL SPECIALTIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
WORLD BIO TECH CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 5 |
| Total Device Problems | 5 |