Nitinol Gentle Touch Coil Spring
FDA 510(k) K923839 · Ultimate Wireforms, Inc.
510(k) numberK923839
Submission
- Device name
- Nitinol Gentle Touch Coil Spring
- Applicant
- Ultimate Wireforms, Inc.
Terryville, CT, US - Received
- July 30, 1992
- Decision date
- October 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code DZC
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|---|---|---|---|
| K112640 | Hyperelastic WireDZC · Traditional | Ormco Corp. | 11/16/2011SE |
| K943334 | Hawley Retainer Orthodontic Applicance KitDZC · Traditional | Jay H. Geller | 10/05/1994SE |
| K935638 | Nitinol, NitiDZC · Traditional | Highland Metals | 05/18/1994SE |
| K935140 | Dentaurum Steel Ligature WiresDZC · Traditional | Dentauraum, Inc. | 02/04/1994SE |
| K935142 | Dentaurum WiresDZC · Traditional | Dentauraum, Inc. | 01/31/1994SE |
| K934265 | Flexmedics Super-Seven Stranded Nickel-Titanium ArchwireDZC · Traditional | Flexmedics | 01/21/1994SE |
| K933374 | Niti Coil SpringsDZC · Traditional | Highland Metals | 11/19/1993SE |
| K933377 | Stainless Steel Arches Repacker RelabeterDZC · Traditional | Highland Metals | 11/16/1993SE |
| K933380 | Reverse Surve Niti Arch WireDZC · Traditional | Highland Metals | 11/12/1993SE |
| K933379 | Stainless Steel ArchesDZC · Traditional | Highland Metals | 11/12/1993SE |
More from Highland Metals
| 510(k) | Device | Decision |
|---|---|---|
| K960799 | Ortho-IceEAT · Traditional | 05/09/1996SE |
| K924805 | Orthodontic Arch WireDZC · Traditional | 03/31/1993SE |
| K923837 | Dimpled Multi Modulus Arch WireDZC · Traditional | 03/31/1993SE |
| K923836 | .016' X .016 Nickel Titanium Uprighting SpringDZC · Traditional | 12/23/1992SE |
| K923838 | The Ultimate RCS Arch WireDZC · Traditional | 12/04/1992SE |
Questions and answers
When was Nitinol Gentle Touch Coil Spring cleared by the FDA?
Nitinol Gentle Touch Coil Spring (K923839) received a 510(k) decision of Substantially Equivalent on October 15, 1992, 77 days after the submission was received.
What is the product code of K923839?
The FDA product code is DZC – Wire, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.5410.