Nickle-Titanium Orthodontic Wire
FDA 510(k) K891327 · American Orthodontics
510(k) numberK891327
Submission
- Device name
- Nickle-Titanium Orthodontic Wire
- Applicant
- American Orthodontics
Sheboygan, WI, US - Received
- March 10, 1989
- Decision date
- May 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJF – Detector, Air Bubble
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K904992 | Minnilert Air DetectorFJF · Traditional | Minntech Corp. | 02/05/1991SE |
| K781330 | Blood Level Detector-Model 7601FJF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/31/1978SE |
| K780582 | Detector, Bubble & FoamFJF · Traditional | Hospal Medical Corp. | 06/22/1978SE |
| K770857 | Dialysis Machine, Centry IIFJF · Traditional | Cobe Laboratories, Inc. | 10/04/1977SE |
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Questions and answers
When was Nickle-Titanium Orthodontic Wire cleared by the FDA?
Nickle-Titanium Orthodontic Wire (K891327) received a 510(k) decision of Substantially Equivalent on May 10, 1989, 61 days after the submission was received.
What is the product code of K891327?
The FDA product code is FJF – Detector, Air Bubble, a Class II (moderate risk) device regulated under 21 CFR 876.5820.