Oberto Mouth Prop
FDA 510(k) K864962 · Medovations, Inc.
510(k) numberK864962
Submission
- Device name
- Oberto Mouth Prop
- Applicant
- Medovations, Inc.
Milwaukee, WI, US - Received
- December 22, 1986
- Decision date
- February 19, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| K221469 | PATI (Protector Against Tongue Injury)JXL · Traditional | Neurovice, LLC | 02/22/2023SE |
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| K172978 | SurgeoBiteJXL · Traditional | Surgovations, LLC | 12/22/2017SE |
| K150518 | Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue…JXL · Traditional | Dupaco, Inc. | 06/29/2015SE |
| K050188 | EpiguardJXL · Traditional | Episafe Medical Devices, Ltd. | 04/27/2005SE |
| K992269 | Ventil-A Oral ProtectorJXL · Traditional | Somatics, Inc. | 10/25/1999SE |
| K960663 | Universal Bite BlockJXL · Traditional | B&B Medical Technologies, Inc. | 05/17/1996SE |
| K954352 | Bite BlockJXL · Traditional | United States Endoscopy Group, Inc. | 01/25/1996SE |
| K941856 | Premier Promax Bite GuardJXL · Traditional | Premier Dental Products Co. | 04/05/1995SE |
| K924333 | The Davis Disposable Protective SplintJXL · Traditional | Ora-Gard, Inc. | 04/23/1993SE |
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| K002363 | Medovations Esophageal DilatorKNQ · Traditional | 11/01/2000SE |
| K972119 | Maloney Bouge (1210-XX)/HURST Bougie (1212-XX)FAT · Traditional | 02/02/1998SE |
| K924646 | Over the Guidewire Dilatation SystemKNQ · Traditional | 12/05/1994SE |
| K913678 | Trocar CatheterKGY · Traditional | 12/16/1991SE |
| K905478 | Yankauer Suction DeviceMDM · Traditional | 12/19/1990SE |
| K874309 | Urethal CatheterKNX · Traditional | 12/07/1987SE |
| K864963 | Stomach Evaculator - Ewald StyleKOA · Traditional | 10/14/1987SE |
| K864964 | 5 - in - 1 ConnectorGAZ · Traditional | 01/20/1987SE |
| K854616 | Enteral Feeding BagKNT · Traditional | 01/23/1986SE |
Questions and answers
When was Oberto Mouth Prop cleared by the FDA?
Oberto Mouth Prop (K864962) received a 510(k) decision of Substantially Equivalent on February 19, 1987, 59 days after the submission was received.
What is the product code of K864962?
The FDA product code is JXL – Block, Bite, a Class II (moderate risk) device regulated under 21 CFR 882.5070.