Cement, Ear, Nose And Throat
The Cement, Ear, Nose And Throat (product code NEA) is a dental/ENT cement material used to bond or seal structures in ear, nose, and throat surgical procedures, such as ossicular reconstruction or tympanoplasty. It is classified as an FDA Class 2 device within the Dental specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NEA
- Device Class
- FDA class 2
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140644 | PROCEM | Jun 19, 2014 | Substantially Equivalent | Ototronix, LLC |
| K080032 | ENVOYCEM, MODEL 1640 | Feb 28, 2008 | Substantially Equivalent | Envoy Medical Corporation |
| K060750 | STRYKER INJECTABLE CEMENT | Apr 19, 2006 | Substantially Equivalent | Stryker Cmf |
| K042516 | OTOMIMIX | Nov 08, 2004 | Substantially Equivalent | Walter Lorenz Surgical, Inc. |
| K011338 | OTO-CEM | Sep 13, 2001 | Substantially Equivalent | Ototech, Inc. |
| K003567 | SERENOCEM, MODEL BC 010 | Feb 12, 2001 | Substantially Equivalent | Corinthian Medical , Ltd. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.