Surgical Contra-Angle Handpieces, Models 975 AE,979 E/Km, 985 Ae, 986 Ae, 988 E/Km and Surgical Straight Handpieces Mod
FDA 510(k) K984508 · W&H Dentalwerk Buermoos GmbH
510(k) numberK984508
Submission
- Device name
- Surgical Contra-Angle Handpieces, Models 975 AE,979 E/Km, 985 Ae, 986 Ae, 988 E/Km and Surgical Straight Handpieces Mod
- Applicant
- W&H Dentalwerk Buermoos GmbH
Buermoos, AT - Received
- December 18, 1998
- Decision date
- June 25, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K962979 | S-53 Introral Dental SystemDZA · Traditional | Del Medical Systems Corp. | 09/25/1996SE |
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| K905418 | Gates Glidden DrillsDZA · Traditional | The Hygenic Corp. | 07/25/1991SE |
| K901097 | Fillock ReamerDZA · Traditional | Ivoclar North America, Inc. | 04/25/1990SE |
| K896149 | Anest-Eze Dental Drill RA#2DZA · Traditional | Signature One Products, Inc. | 01/19/1990SE |
| K884187 | Indentec Drill Ra #1DZA · Traditional | Phillip C. Crawford, D.D.S. | 12/22/1988SE |
| K811113 | Riess-LuhrDZA · Traditional | Allomedic | 06/16/1981SE |
| K801888 | Handpiece, DentalDZA · Traditional | Aesculap Instruments Corp. | 08/20/1980SE |
| K801887 | Drill, DentalDZA · Traditional | Aesculap Instruments Corp. | 08/20/1980SE |
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Questions and answers
When was Surgical Contra-Angle Handpieces, Models 975 AE,979 E/Km, 985 Ae, 986 Ae, 988 E/Km and Surgical Straight Handpieces Mod cleared by the FDA?
Surgical Contra-Angle Handpieces, Models 975 AE,979 E/Km, 985 Ae, 986 Ae, 988 E/Km and Surgical Straight Handpieces Mod (K984508) received a 510(k) decision of Substantially Equivalent on June 25, 1999, 189 days after the submission was received.
What is the product code of K984508?
The FDA product code is DZA – Drill, Dental, Intraoral, a Class I (low risk) device regulated under 21 CFR 872.4130.