Dentaurum Wires
FDA 510(k) K935142 · Dentauraum, Inc.
510(k) numberK935142
Submission
- Device name
- Dentaurum Wires
- Applicant
- Dentauraum, Inc.
Newtown, PA, US - Received
- October 28, 1993
- Decision date
- January 31, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code DZC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K933378 | Reverse Curve Niti Arch Wire Repacker RelabeterDZC · Traditional | Highland Metals | 11/12/1993SE |
More from Highland Metals
| 510(k) | Device | Decision |
|---|---|---|
| K952870 | Remanium: CS & G-SoftEJH · Traditional | 07/27/1995SE |
| K952867 | Remanium:Gm 700, GM 380, GM 800, GFHEJH · Traditional | 07/27/1995SE |
| K952866 | Rematitan TitaniumEJH · Traditional | 07/27/1995SE |
| K952865 | Remanium: 200,CS, 380, and CDEJH · Traditional | 07/26/1995SE |
| K952868 | Dentaurum Jacket Crown & Root PostsEBL · Traditional | 07/19/1995SE |
| K942667 | Dent-O-Cryl Orthodontic AcrylicKMY · Traditional | 02/13/1995SE |
| K942666 | Orthalgenat Impression MaterialELW · Traditional | 08/10/1994SE |
| K936151 | Extraoral HeadgearDZB · Traditional | 08/01/1994SE |
| K942668 | O-Tray Impression TraysEHY · Traditional | 07/22/1994SE |
| K942665 | Orthocent: Liquid and PowderEMA · Traditional | 07/22/1994SE |
Questions and answers
When was Dentaurum Wires cleared by the FDA?
Dentaurum Wires (K935142) received a 510(k) decision of Substantially Equivalent on January 31, 1994, 95 days after the submission was received.
What is the product code of K935142?
The FDA product code is DZC – Wire, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.5410.