Reflections - Ceramic Dental Bracket
FDA 510(k) K922499 · Cdb Corp.
510(k) numberK922499
Submission
- Device name
- Reflections - Ceramic Dental Bracket
- Applicant
- Cdb Corp.
Wilmington, NC, US - Received
- May 27, 1992
- Decision date
- July 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EJF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K994357 | Bitem Lock, Models SW006, SW012EJF · Traditional | Thermoelastic Technologies, Inc. | 03/14/2000SE |
| K932825 | Microarch Gold BracketEJF · Traditional | Gac Intl., Inc. | 05/09/1994SE |
| K933501 | AlastikEJF · Traditional | Unitek Corp. | 04/28/1994SE |
| K923372 | Memory WireEJF · Traditional | Althan, Inc. | 04/22/1994SE |
| K933080 | Orthotech Dura-Gold BarcketsEJF · Traditional | Orthotech | 03/23/1994SE |
| K935139 | Fascination Ceramic BracketEJF · Traditional | Dentauraum, Inc. | 02/04/1994SE |
| K936244 | Regency BracketEJF · Traditional | Mid-American Dental Specialties, Inc. | 02/02/1994SE |
| K934881 | ReflectionsEJF · Traditional | Cdb Corp. | 02/01/1994SE |
| K935122 | Dentaurum Metal BracketsEJF · Traditional | Dentauraum, Inc. | 01/31/1994SE |
| K926427 | Lariat Palate ExpanderEJF · Traditional | Easy Access Orthodontics, Inc. | 01/26/1994SE |
More from Easy Access Orthodontics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212173 | HDH Treatment Planning SystemPNN · Traditional | 01/25/2022SE |
| K210613 | HIT Clear AlignerNXC · Special | 06/04/2021SE |
| K191823 | Clear-AlignersNXC · Traditional | 12/20/2019SE |
| K160957 | CDB Self Ligating Bracket 8FNJM · Traditional | 09/27/2016SE |
| K091702 | CDB Flip-Side-Clip BracketNJM · Traditional | 08/07/2009SE |
| K080906 | CDB ClipNJM · Traditional | 10/17/2008SE |
| K973776 | ReflectionsDYW · Traditional | 11/21/1997SE |
| K934881 | ReflectionsEJF · Traditional | 02/01/1994SE |
Questions and answers
When was Reflections - Ceramic Dental Bracket cleared by the FDA?
Reflections - Ceramic Dental Bracket (K922499) received a 510(k) decision of Substantially Equivalent on July 30, 1992, 64 days after the submission was received.
What is the product code of K922499?
The FDA product code is EJF – Bracket, Metal, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.5410.