F.G. Laser (Dental Bur)
FDA 510(k) K901262 · Diamond Rotary and Carbide Intl.
510(k) numberK901262
Submission
- Device name
- F.G. Laser (Dental Bur)
- Applicant
- Diamond Rotary and Carbide Intl.
Canada R3c 4e5, CA - Received
- March 16, 1990
- Decision date
- July 9, 1990
- 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 |
| 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 |
| K885233 | Nova DiamondDZP · Traditional | Microcopy, Div. Neo-Flo, Inc. | 02/13/1989SE |
Questions and answers
When was F.G. Laser (Dental Bur) cleared by the FDA?
F.G. Laser (Dental Bur) (K901262) received a 510(k) decision of Substantially Equivalent on July 9, 1990, 115 days after the submission was received.
What is the product code of K901262?
The FDA product code is DZP – Instrument, Diamond, Dental, a Class I (low risk) device regulated under 21 CFR 872.4535.