Non-Fogging Dental Mirror
FDA 510(k) K941954 · Buffalo Dental Mfg. Co., Inc.
510(k) numberK941954
Submission
- Device name
- Non-Fogging Dental Mirror
- Applicant
- Buffalo Dental Mfg. Co., Inc.
Syosset, NY, US - Received
- April 22, 1994
- Decision date
- July 8, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
| K925115 | Amd Dentist and Hygienist KitsEKJ · Traditional | Advance Medical Designs, Inc. | 07/05/1994SE |
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| K841491 | Conventional Plastic Dental TraysEHY · Traditional | 07/13/1984SE |
| K841490 | Polysulfide Custom Tray MaterialELW · Traditional | 06/27/1984SE |
| K841323 | Fuzzy TrayEHY · Traditional | 06/27/1984SE |
| K820489 | Ultrafine Tray AdhesiveELW · Traditional | 03/19/1982SE |
| K820216 | Ultra-WetELW · Traditional | 02/24/1982SE |
| K802990 | Alginate/Silicone Crown & Bridge MaterELW · Traditional | 02/02/1981SE |
| K802882 | Hydrocolloid Compatible Cream AlginateELW · Traditional | 01/28/1981SE |
| K802662 | Polycarbonate Temporary CementEMA · Traditional | 12/16/1980SE |
Questions and answers
When was Non-Fogging Dental Mirror cleared by the FDA?
Non-Fogging Dental Mirror (K941954) received a 510(k) decision of Substantially Equivalent on July 8, 1994, 77 days after the submission was received.
What is the product code of K941954?
The FDA product code is EKJ – Burnisher, Operative, a Class I (low risk) device regulated under 21 CFR 872.4565.