S-53 Introral Dental System
FDA 510(k) K962979 · Del Medical Systems Corp.
510(k) numberK962979
Submission
- Device name
- S-53 Introral Dental System
- Applicant
- Del Medical Systems Corp.
Valhalla, NY, US - Received
- July 31, 1996
- Decision date
- September 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984508 | Surgical Contra-Angle Handpieces, Models 975 AE,979 E/Km, 985 Ae, 986 Ae, 988 E/Km and…DZA · Traditional | W&H Dentalwerk Buermoos GmbH | 06/25/1999SE |
| K954790 | Profile Nickel Titanium Rotary InstrumentsDZA · Traditional | Tulsa Dental Products, Ltd. | 01/16/1996SE |
| K914724 | Ada Shank ExtensionDZA · Traditional | Implant Corp. of America | 07/27/1993SE |
| 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 |
More from Aesculap Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K962684 | S-357 Video Imaging SystemGCJ · Traditional | 10/15/1996SE |
| K962651 | S-52 Electronic Video LaparoscopeGCJ · Traditional | 09/30/1996SE |
| K960301 | ND VISION-220 Adaptive Image ProcessessorGCJ · Traditional | 09/30/1996SE |
| K962020 | S-41 & S-41S Video Imaging SystemGCJ · Traditional | 08/30/1996SE |
| K962024 | S-57 Video Imaging SystemFET · Traditional | 07/09/1996SE |
| K942924 | MSV-2000 Video Imaging SystemGCJ · Traditional | 10/03/1994SE |
Questions and answers
When was S-53 Introral Dental System cleared by the FDA?
S-53 Introral Dental System (K962979) received a 510(k) decision of Substantially Equivalent on September 25, 1996, 56 days after the submission was received.
What is the product code of K962979?
The FDA product code is DZA – Drill, Dental, Intraoral, a Class I (low risk) device regulated under 21 CFR 872.4130.