Reflections
FDA 510(k) K934881 · Cdb Corp.
510(k) numberK934881
Submission
- Device name
- Reflections
- Applicant
- Cdb Corp.
Wilmington, NC, US - Received
- October 12, 1993
- Decision date
- February 1, 1994
- 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 |
| K935122 | Dentaurum Metal BracketsEJF · Traditional | Dentauraum, Inc. | 01/31/1994SE |
| K926427 | Lariat Palate ExpanderEJF · Traditional | Easy Access Orthodontics, Inc. | 01/26/1994SE |
| K925028 | Forestadent Orthodontic BandsEJF · Traditional | Forestadent | 01/26/1994SE |
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| K091702 | CDB Flip-Side-Clip BracketNJM · Traditional | 08/07/2009SE |
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| K973776 | ReflectionsDYW · Traditional | 11/21/1997SE |
| K922499 | Reflections - Ceramic Dental BracketEJF · Traditional | 07/30/1992SE |
Questions and answers
When was Reflections cleared by the FDA?
Reflections (K934881) received a 510(k) decision of Substantially Equivalent on February 1, 1994, 112 days after the submission was received.
What is the product code of K934881?
The FDA product code is EJF – Bracket, Metal, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.5410.