Diamond Stones
FDA 510(k) K760987 · Adp Intl., Inc.
510(k) numberK760987
Submission
- Device name
- Diamond Stones
- 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 DZP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120037 | Bluwhite Diamond Dental Burs ModifiedDZP · Traditional | Beavers Dental, Div. Sybron Canada, Ltd. | 04/20/2012SE |
| K943841 | Sophos Dental DiamondDZP · Traditional | Sophos Technologic | 09/16/1994SE |
| K940908 | Dunhall/Omnii International Rotary Diamond BursDZP · Traditional | Dunhall Pharmaceuticals, Inc. | 08/29/1994SE |
| K934981 | Dental DrillDZP · Traditional | Eare Consulting Service | 02/03/1994SE |
| K923757 | Dental Diamond DrillsDZP · Traditional | Alpha Industrializacao DE Metais Ltda. | 03/16/1993SE |
| K913651 | Mani Dia-BursDZP · Traditional | The Lahr Consulting Group, Inc. | 01/14/1992SE |
| K901967 | Dendia Werk Burs and Cutting DiscsDZP · Traditional | Micro-Aire Surgical Instruments, Inc. | 07/13/1990SE |
| K901262 | F.G. Laser (Dental Bur)DZP · Traditional | Diamond Rotary and Carbide Intl. | 07/09/1990SE |
| K900089 | FG Diamond BurrsDZP · Traditional | Kab Gloves Unltd. | 04/03/1990SE |
| K893844 | 3D Dental Diamond Rotary InstrumentsDZP · Traditional | Lustgarten Multi-Tech International, Inc. | 08/11/1989SE |
More from Lustgarten Multi-Tech International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K760988 | Dental Handpieces · 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 |
| 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 Diamond Stones cleared by the FDA?
Diamond Stones (K760987) 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 K760987?
The FDA product code is DZP – Instrument, Diamond, Dental, a Class I (low risk) device regulated under 21 CFR 872.4535.