Amd Dentist and Hygienist Kits
FDA 510(k) K925115 · Advance Medical Designs, Inc.
510(k) numberK925115
Submission
- Device name
- Amd Dentist and Hygienist Kits
- Applicant
- Advance Medical Designs, Inc.
Marietta, GA, US - Received
- October 9, 1992
- Decision date
- July 5, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K961714 | Aseptylum, Uni-CarrierEKJ · Traditional | Distriflor S.A. | 06/10/1996SE |
| K953707 | Medtrol Dental KitEKJ · Traditional | Medtrol, Inc. | 01/04/1996SE |
| K945815 | Dental KitEKJ · Traditional | Constancy Ent., Inc. | 07/19/1995SE |
| K951607 | Sureflex FilesEKJ · Traditional | Dentsply Intl. | 06/22/1995SE |
| K945077 | Instrument,Filling,Plastic,DentalEKJ · Traditional | Worldwide Dental, Inc. | 11/30/1994SE |
| K943820 | Stat PakEKJ · Traditional | Magnum Instruments, Inc. | 11/02/1994SE |
| K943351 | Maunal Disposable Dental InstrumentsEKJ · Traditional | Magnum Instruments, Inc. | 10/07/1994SE |
| K943584 | Presterilized Endodontic FilesEKJ · Traditional | Dentsply Intl. | 09/21/1994SE |
| K935127 | Southland Sterile Dental SystemEKJ · Traditional | Southland, Ltd. | 07/28/1994SE |
| K941954 | Non-Fogging Dental MirrorEKJ · Traditional | Buffalo Dental Mfg. Co., Inc. | 07/08/1994SE |
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| K053495 | Equipment Slush DrapeKKX · Traditional | 03/16/2006SE |
| K011265 | Ultrasound Transducer CoverITX · Traditional | 10/30/2001SE |
| K012168 | Advance Medical Designs Fluid PouchKKX · Traditional | 09/18/2001SE |
| K011422 | Surgical DrapesKKX · Traditional | 07/10/2001SE |
| K003670 | Patient Drape, SurgicalKKX · Traditional | 01/26/2001SE |
| K911884 | Advance Pressure Monitor/High Pressure LinesDTL · Traditional | 07/05/1994SE |
| K915301 | Advance Stopcock/High Pressure StopcockDTL · Traditional | 12/11/1992SE |
| K911732 | Advance Disposable Control SyringeIZI · Traditional | 09/16/1991SE |
Questions and answers
When was Amd Dentist and Hygienist Kits cleared by the FDA?
Amd Dentist and Hygienist Kits (K925115) received a 510(k) decision of Substantially Equivalent on July 5, 1994, 634 days after the submission was received.
What is the product code of K925115?
The FDA product code is EKJ – Burnisher, Operative, a Class I (low risk) device regulated under 21 CFR 872.4565.