Epiguard
FDA 510(k) K050188 · Episafe Medical Devices, Ltd.
510(k) numberK050188
Submission
- Device name
- Epiguard
- Applicant
- Episafe Medical Devices, Ltd.
Somerset, MA, US - Received
- January 27, 2005
- Decision date
- April 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K924304 | Bite BlockJXL · Traditional | United States Endoscopy Group, Inc. | 04/06/1993SE |
Questions and answers
When was Epiguard cleared by the FDA?
Epiguard (K050188) received a 510(k) decision of Substantially Equivalent on April 27, 2005, 90 days after the submission was received.
What is the product code of K050188?
The FDA product code is JXL – Block, Bite, a Class II (moderate risk) device regulated under 21 CFR 882.5070.