Dendia Werk Burs and Cutting Discs
FDA 510(k) K901967 · Micro-Aire Surgical Instruments, Inc.
510(k) numberK901967
Submission
- Device name
- Dendia Werk Burs and Cutting Discs
- Applicant
- Micro-Aire Surgical Instruments, Inc.
Valencia, CA, US - Received
- May 1, 1990
- Decision date
- July 13, 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 |
| 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 |
| K885233 | Nova DiamondDZP · Traditional | Microcopy, Div. Neo-Flo, Inc. | 02/13/1989SE |
More from Microcopy, Div. Neo-Flo, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K904949 | A.O. Synthes,Tap(Replacement)Various Model NumbersHSZ · Traditional | 11/26/1990SE |
| K903713 | Osteotome Model Numbers 2500-228 & 2500-229HSZ · Traditional | 09/14/1990SE |
| K903650 | Oscillating Saw Blades # SO-305,MO-305 and ZO-305HWE · Traditional | 09/14/1990SE |
| K902676 | Microguard, Orthopedic Pin ProtectorsLYT · Traditional | 09/14/1990SE |
| K903664 | Micro-Aire Wire Pass and Craniotome DrillHBE · Traditional | 09/13/1990SE |
| K902168 | Arthroscopic Surgery Blades (Several Models)HRX · Traditional | 06/20/1990SE |
| K901735 | Arthroscopic Surgery Blades DY-3440, 3443, 3444HRX · Traditional | 06/20/1990SE |
| K900033 | Micro-Aire Powered Micro-Surgery InstrumentsGEY · Traditional | 02/13/1990SE |
| K900210 | Bone Harvester System & Osteotome System 2500HSZ · Traditional | 02/02/1990SE |
| K896280 | Micro-Aire Oscillating Saw Blade 202C-25, 202C-50GFA · Traditional | 11/22/1989SE |
Questions and answers
When was Dendia Werk Burs and Cutting Discs cleared by the FDA?
Dendia Werk Burs and Cutting Discs (K901967) received a 510(k) decision of Substantially Equivalent on July 13, 1990, 73 days after the submission was received.
What is the product code of K901967?
The FDA product code is DZP – Instrument, Diamond, Dental, a Class I (low risk) device regulated under 21 CFR 872.4535.