Hand Instruments
FDA 510(k) K760985 · Adp Intl., Inc.
510(k) numberK760985
Submission
- Device name
- Hand Instruments
- Applicant
- Adp Intl., Inc.
Mchenry, IL, US - Received
- October 21, 1976
- Decision date
- November 15, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EKW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K823489 | Endodontic Broach-Barbed BroachEKW · Traditional | Union Broach, Div. Moyco Industries, Inc. | 12/15/1982SE |
| K800292 | Endex Broach, EndodonticEKW · Traditional | Ipco Corp. | 02/19/1980SE |
More from Ipco Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K760988 | Dental Handpieces · Traditional | 11/15/1976SE |
| K760987 | Diamond StonesDZP · Traditional | 11/15/1976SE |
| K760986 | Carbide Dental BursEJL · Traditional | 11/15/1976SE |
| K760984 | Orthodontic InstrumentsJEX · Traditional | 11/15/1976SE |
| K760983 | Endodontic InstrumentsEKN · Traditional | 11/15/1976SE |
| K760982 | Dental VarnishLBH · Traditional | 11/15/1976SE |
| K760981 | Alginate Impression MaterialELW · Traditional | 11/15/1976SE |
| K760980 | Dental AlloyEJJ · Traditional | 11/15/1976SE |
| K760979 | Composite MaterialEBF · Traditional | 11/15/1976SE |
| K760978 | Zinc CementEMA · Traditional | 11/15/1976SE |
Questions and answers
When was Hand Instruments cleared by the FDA?
Hand Instruments (K760985) received a 510(k) decision of Substantially Equivalent on November 15, 1976, 25 days after the submission was received.
What is the product code of K760985?
The FDA product code is EKW – Broach, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.