Root Canal Reamers, Type K
FDA 510(k) K822620 · Union Broach, Div. Moyco Industries, Inc.
510(k) numberK822620
Submission
- Device name
- Root Canal Reamers, Type K
- Applicant
- Union Broach, Div. Moyco Industries, Inc.
Mchenry, IL, US - Received
- August 30, 1982
- Decision date
- September 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EKP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K823686 | Reamer Type K EndodonticEKP · Traditional | United Dental Mfg., Inc. | 12/28/1982SE |
| K800291 | Endex Reamers Pulp Canal, EndodonticEKP · Traditional | Ipco Corp. | 02/19/1980SE |
| K770331 | Dialysis, Jet SystemEKP · Traditional | Janneck Ent. of Texas | 04/20/1977SE |
| K770598 | Endodontic Instruments, R&R CutwellEKP · Traditional | Ransom and Randolph | 04/05/1977SE |
| K770367 | Root Canal Files & ReamersEKP · Traditional | Cemco Tool Co., Inc. | 03/01/1977SE |
More from Cemco Tool Co., Inc.
| 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 |
| 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 Root Canal Reamers, Type K cleared by the FDA?
Root Canal Reamers, Type K (K822620) received a 510(k) decision of Substantially Equivalent on September 28, 1982, 29 days after the submission was received.
What is the product code of K822620?
The FDA product code is EKP – Reamer, Pulp Canal, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.