Tum-E-Vac Bite Block
FDA 510(k) K921946 · Ethox Corp.
510(k) numberK921946
Submission
- Device name
- Tum-E-Vac Bite Block
- Applicant
- Ethox Corp.
Buffalo, NY, US - Received
- April 27, 1992
- Decision date
- December 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K992269 | Ventil-A Oral ProtectorJXL · Traditional | Somatics, Inc. | 10/25/1999SE |
| K960663 | Universal Bite BlockJXL · Traditional | B&B Medical Technologies, Inc. | 05/17/1996SE |
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| K941856 | Premier Promax Bite GuardJXL · Traditional | Premier Dental Products Co. | 04/05/1995SE |
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| K031195 | Cuf-Cover (TM)DXQ · Traditional | 10/10/2003SE |
| K962850 | Tum-E-VacKDH · Traditional | 02/21/1997SE |
| K935633 | No-MesKNT · Traditional | 09/30/1994SE |
| K885220 | Percutaneous Endoscopic Gastrostomy KitKNT · Traditional | 09/25/1989SEKD |
| K894927 | Surgi SqueezKZD · Traditional | 09/11/1989SE |
| K883977 | Surgi-Cuf Sterile/Non-Sterile DisposableDXQ · Traditional | 02/10/1989SE |
| K860599 | Ethox Lavage TubeKDH · Traditional | 03/11/1986SE |
| K844988 | Ethox Neonatal Blood Pressure Cuff-Sterile/Dispos.DXQ · Traditional | 04/04/1985SE |
| K841512 | Ethox Relia-Flo 2001 Enteral FeedFRN · Traditional | 05/21/1984SE |
Questions and answers
When was Tum-E-Vac Bite Block cleared by the FDA?
Tum-E-Vac Bite Block (K921946) received a 510(k) decision of Substantially Equivalent on December 9, 1992, 226 days after the submission was received.
What is the product code of K921946?
The FDA product code is JXL – Block, Bite, a Class II (moderate risk) device regulated under 21 CFR 882.5070.