Shaping Hedstrom N.T.
FDA 510(k) K953604 · Sybron Dental Specialties, Inc.
510(k) numberK953604
Submission
- Device name
- Shaping Hedstrom N.T.
- Applicant
- Sybron Dental Specialties, Inc.
Glendora, CA, US - Received
- August 2, 1995
- Decision date
- September 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| 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 |
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| K160097 | Image Fast Set, Image Regular SetELW · Traditional | 08/05/2016SE |
| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressKIF · Traditional | 07/27/2016SE |
| K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWTKIF · Traditional | 05/06/2016SE |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesKIF · Special | 04/14/2016SE |
| K151526 | Zone, ZoneFree, Zone A1EMA · Traditional | 09/10/2015SE |
| K151332 | Nexus Universal, Nexus Universal ChromaEMA · Abbreviated | 08/17/2015SE |
| K150559 | Life Fast Set, Life Regular SetEJK · Special | 06/19/2015SE |
| K143209 | SonicFill 2EBF · Traditional | 02/05/2015SE |
Questions and answers
When was Shaping Hedstrom N.T. cleared by the FDA?
Shaping Hedstrom N.T. (K953604) received a 510(k) decision of Substantially Equivalent on September 28, 1995, 57 days after the submission was received.
What is the product code of K953604?
The FDA product code is EKS – File, Pulp Canal, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.