Endodontic Instruments
FDA 510(k) K760983 · Adp Intl., Inc.
510(k) numberK760983
Submission
- Device name
- Endodontic 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 EKN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K843017 | Absorbent Endodontic PointEKN · Traditional | United Dental Mfg., Inc. | 01/09/1985SE |
| K821625 | Endodontic PaperpointsEKN · Traditional | Roeko | 06/14/1982SE |
| K812886 | Endodontic Paper PointsEKN · Traditional | United Dental Mfg., Inc. | 11/16/1981SE |
| K800827 | Premier Absorbent PointsEKN · Traditional | Premier Dental Products Co. | 04/29/1980SE |
| K781605 | R&R Absorbent PointsEKN · Traditional | Ransom and Randolph | 10/10/1978SE |
| K761203 | Absorbent PointsEKN · Traditional | Johnson & Johnson Professionals, Inc. | 12/13/1976SE |
More from Johnson & Johnson Professionals, Inc.
| 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 |
| K760985 | Hand InstrumentsEKW · Traditional | 11/15/1976SE |
| K760984 | Orthodontic InstrumentsJEX · 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 Endodontic Instruments cleared by the FDA?
Endodontic Instruments (K760983) 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 K760983?
The FDA product code is EKN – Point, Paper, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.3830.