Accessories, Retractor, Dental
Dental Retractor Accessories are supplementary components such as cheek retractors, lip retractors, and tongue guards used alongside retractor devices to improve visibility, protect soft tissues, and maintain access to the oral cavity during dental procedures. They are classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EIF, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EIF
- Device Class
- FDA class 1
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K940785 | MOUTH PROPS | Oct 05, 1994 | Substantially Equivalent | Worldwide Dental, Inc. |
| K873960 | LEWIS SAFE SLEEVE | Dec 04, 1987 | Substantially Equivalent | Cheri Lewis, D.D.S. |
| K830187 | FOCUS FLUID | Mar 01, 1983 | Substantially Equivalent | Hematology Marketing Assoc. |
| K830116 | SULCARINGS | Feb 18, 1983 | Substantially Equivalent | North Pacific Dental, Inc. |
FEI Numbers
This FDA classification entry is associated with 165 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 165 registration numbers. Click on an entry to view related FDA registrations.