Endodontic Broach-Barbed Broach
FDA 510(k) K823489 · Union Broach, Div. Moyco Industries, Inc.
510(k) numberK823489
Submission
- Device name
- Endodontic Broach-Barbed Broach
- Applicant
- Union Broach, Div. Moyco Industries, Inc.
Mchenry, IL, US - Received
- November 23, 1982
- Decision date
- December 15, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EKW
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|---|---|---|---|
| K871493 | Denti-Tray(Tm)EKW · Traditional | Advanced Medical, Inc. | 06/24/1987SE |
| K870765 | Cannulated Instrument CleanersEKW · Traditional | Treace Medical, Inc. | 05/27/1987SE |
| K862523 | Man Surg Instr/Access Dumbach Titan Mesh Impl SysEKW · Traditional | Walter Lorenz Surgical, Inc. | 08/01/1986SE |
| K831749 | Endodontic BROACH(76EKN) Barbed BroachEKW · Traditional | Union Branch | 07/12/1983SE |
| K800292 | Endex Broach, EndodonticEKW · Traditional | Ipco Corp. | 02/19/1980SE |
| K760985 | Hand InstrumentsEKW · Traditional | Adp Intl., Inc. | 11/15/1976SE |
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| K950365 | Moyco-EdtaKJJ · Traditional | 04/27/1995SE |
| K941574 | Retro MirrorEAX · Traditional | 05/18/1994SE |
| K940260 | Thermal Pulp TesterEAT · Traditional | 03/07/1994SE |
| K935542 | Nickel-Titanium K-Type FileEKS · Traditional | 01/03/1994SE |
| 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 |
Questions and answers
When was Endodontic Broach-Barbed Broach cleared by the FDA?
Endodontic Broach-Barbed Broach (K823489) received a 510(k) decision of Substantially Equivalent on December 15, 1982, 22 days after the submission was received.
What is the product code of K823489?
The FDA product code is EKW – Broach, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.