Profile Series 29 Files
FDA 510(k) K933582 · Tulsa Dental Products, Ltd.
510(k) numberK933582
Submission
- Device name
- Profile Series 29 Files
- Applicant
- Tulsa Dental Products, Ltd.
Tulsa, OK, US - Received
- July 23, 1993
- Decision date
- October 20, 1993
- 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 |
| K935542 | Nickel-Titanium K-Type FileEKS · Traditional | Union Broach, Div. Moyco Industries, Inc. | 01/03/1994SE |
| K932529 | Lightspeed Dental Hand InstrumentEKS · Traditional | Lightspeed Endodontics | 11/04/1993SE |
| 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 |
|---|---|---|
| K970134 | Thermaprep Plus OvenEKM · Traditional | 03/21/1997SE |
| K964174 | Mineral Trioxide Aggregate (Mta)KIF · Traditional | 02/10/1997SE |
| K954790 | Profile Nickel Titanium Rotary InstrumentsDZA · Traditional | 01/16/1996SE |
| K922931 | Thermapost Endodontic Root Canal PostELR · Traditional | 05/26/1994SE |
| K910224 | ThermaprepEKM · Traditional | 03/29/1991SE |
| K900986 | Thermafil Endodontic ObturatorEKM · Traditional | 11/13/1990SE |
| K881139 | Thermafil Endodontic ObturatorEKM · Traditional | 04/07/1988SE |
Questions and answers
When was Profile Series 29 Files cleared by the FDA?
Profile Series 29 Files (K933582) received a 510(k) decision of Substantially Equivalent on October 20, 1993, 89 days after the submission was received.
What is the product code of K933582?
The FDA product code is EKS – File, Pulp Canal, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.