Vitrabond Light Cure Glass Ionomer Liner
FDA 510(k) K882821 · 3M Company
510(k) numberK882821
Submission
- Device name
- Vitrabond Light Cure Glass Ionomer Liner
- Applicant
- 3M Company
Cottae Grove, MN, US - Received
- July 8, 1988
- Decision date
- September 15, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EKJ
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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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| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
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Questions and answers
When was Vitrabond Light Cure Glass Ionomer Liner cleared by the FDA?
Vitrabond Light Cure Glass Ionomer Liner (K882821) received a 510(k) decision of Substantially Equivalent on September 15, 1988, 69 days after the submission was received.
What is the product code of K882821?
The FDA product code is EKJ – Burnisher, Operative, a Class I (low risk) device regulated under 21 CFR 872.4565.