Somatics Mouth Guard (Bite Block)
FDA 510(k) K864181 · Somatics, Inc.
510(k) numberK864181
Submission
- Device name
- Somatics Mouth Guard (Bite Block)
- Applicant
- Somatics, Inc.
Lake Bluff, IL, US - Received
- October 27, 1986
- Decision date
- November 3, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JXL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221469 | PATI (Protector Against Tongue Injury)JXL · Traditional | Neurovice, LLC | 02/22/2023SE |
| K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumJXL · Traditional | Mecta Corporation | 06/04/2021SE |
| 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 |
More from Ora-Gard, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992269 | Ventil-A Oral ProtectorJXL · Traditional | 10/25/1999SE |
| K945120 | Thymatron 2000 Electroconvulsive SystemQGH · Traditional | 10/26/1995SE |
| K890711 | Dual Graph (TM) Recorder-MonitorDSF · Traditional | 06/02/1989SE |
| K890710 | Disposable Eeg/Ekg Electrode, Cat. #EedsGXY · Traditional | 03/14/1989SE |
| K882809 | ThymapadGXY · Traditional | 09/27/1988SE |
| K843923 | ThymatronQGH · Traditional | 12/03/1984SE |
Questions and answers
When was Somatics Mouth Guard (Bite Block) cleared by the FDA?
Somatics Mouth Guard (Bite Block) (K864181) received a 510(k) decision of Substantially Equivalent on November 3, 1986, 7 days after the submission was received.
What is the product code of K864181?
The FDA product code is JXL – Block, Bite, a Class II (moderate risk) device regulated under 21 CFR 882.5070.