Nickel-Titanium K-Type File
FDA 510(k) K935542 · Union Broach, Div. Moyco Industries, Inc.
510(k) numberK935542
Submission
- Device name
- Nickel-Titanium K-Type File
- Applicant
- Union Broach, Div. Moyco Industries, Inc.
Emigsville, PA, US - Received
- November 16, 1993
- Decision date
- January 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EKS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K062856 | TF Rotary Nickel Titanium FileEKS · Traditional | Ormco Corp. | 12/13/2006SE |
| K004031 | NT Swift; Ti\Tec; Gates Glidden Drills; Dental Power Endodontic Hand FilesEKS · Traditional | Dental Power, Inc. | 03/28/2001SE |
| K971319 | NT Series Endodontic Files, Mac Series Endodontic FilesEKS · Traditional | Tycom Dental | 05/22/1997SE |
| K970649 | Hero 642EKS · Traditional | Micro-Mega | 05/16/1997SE |
| K962031 | Quantec Series 2000 Endodontic FilesEKS · Traditional | Tycom Dental | 06/04/1996SE |
| K953604 | Shaping Hedstrom N.T.EKS · Traditional | Sybron Dental Specialties, Inc. | 09/28/1995SE |
| K932529 | Lightspeed Dental Hand InstrumentEKS · Traditional | Lightspeed Endodontics | 11/04/1993SE |
| K933582 | Profile Series 29 FilesEKS · Traditional | Tulsa Dental Products, Ltd. | 10/20/1993SE |
| K902018 | Dentaurum Ceramic Debonding UnitEKS · Traditional | Dentauraum, Inc. | 04/03/1991SE |
| K905640 | Solid Core Gutta Percha CarrierEKS · Traditional | The Hygenic Corp. | 03/05/1991SE |
More from The Hygenic Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K962733 | Cyber-Fil Alkenoate Cement Multi-Purpose Kit (23900/23905/23910/23915/23920)EMA · Traditional | 10/11/1996SE |
| K950365 | Moyco-EdtaKJJ · Traditional | 04/27/1995SE |
| K941574 | Retro MirrorEAX · Traditional | 05/18/1994SE |
| K940260 | Thermal Pulp TesterEAT · Traditional | 03/07/1994SE |
| K931742 | Inject-R FillEKM · Traditional | 05/27/1993SE |
| K923661 | Quadrasorb FilterCAH · Traditional | 10/20/1992SE |
| K895174 | Union Broach Bleaching LightEEG · Traditional | 04/13/1990SE |
| K855136 | Flexor Flexible Roane Tip Endodontic FileEKS · Traditional | 03/06/1986SE |
| K852474 | Union Broach Bleaching Light · Traditional | 07/01/1985SE |
| K823489 | Endodontic Broach-Barbed BroachEKW · Traditional | 12/15/1982SE |
Questions and answers
When was Nickel-Titanium K-Type File cleared by the FDA?
Nickel-Titanium K-Type File (K935542) received a 510(k) decision of Substantially Equivalent on January 3, 1994, 48 days after the submission was received.
What is the product code of K935542?
The FDA product code is EKS – File, Pulp Canal, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.