Memory Wire
FDA 510(k) K923372 · Althan, Inc.
510(k) numberK923372
Submission
- Device name
- Memory Wire
- Applicant
- Althan, Inc.
Cincinnati, OH, US - Received
- July 9, 1992
- Decision date
- April 22, 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 |
| 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 |
| K925028 | Forestadent Orthodontic BandsEJF · Traditional | Forestadent | 01/26/1994SE |
Questions and answers
When was Memory Wire cleared by the FDA?
Memory Wire (K923372) received a 510(k) decision of Substantially Equivalent on April 22, 1994, 652 days after the submission was received.
What is the product code of K923372?
The FDA product code is EJF – Bracket, Metal, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.5410.