Solid Core Gutta Percha Carrier
FDA 510(k) K905640 · The Hygenic Corp.
510(k) numberK905640
Submission
- Device name
- Solid Core Gutta Percha Carrier
- Applicant
- The Hygenic Corp.
Akron, OH, US - Received
- December 17, 1990
- Decision date
- March 5, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K933582 | Profile Series 29 FilesEKS · Traditional | Tulsa Dental Products, Ltd. | 10/20/1993SE |
| K902018 | Dentaurum Ceramic Debonding UnitEKS · Traditional | Dentauraum, Inc. | 04/03/1991SE |
More from Dentauraum, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954990 | Dental DamEIE · Traditional | 01/26/1996SE |
| K930764 | Endo-Ice-Pulp Tester-ThermalEAT · Traditional | 05/27/1993SE |
| K905418 | Gates Glidden DrillsDZA · Traditional | 07/25/1991SE |
| K911225 | Tray DoughKGS · Traditional | 04/17/1991SE |
| K900301 | Novus Bonding AgentEBI · Traditional | 05/15/1990SE |
| K900844 | WedjetsEIE · Traditional | 04/16/1990SE |
| K894092 | Dental Endodontic Cement (Modification)KIF · Traditional | 01/10/1990SE |
| K881826 | Endo-IceEAT · Traditional | 08/23/1988SN |
| K873644 | Pulp PenEAT · Traditional | 10/27/1987SE |
| K863393 | EndocaterLQY · Traditional | 06/11/1987SE |
Questions and answers
When was Solid Core Gutta Percha Carrier cleared by the FDA?
Solid Core Gutta Percha Carrier (K905640) received a 510(k) decision of Substantially Equivalent on March 5, 1991, 78 days after the submission was received.
What is the product code of K905640?
The FDA product code is EKS – File, Pulp Canal, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.