Apron, Leaded
The Leaded Apron is a radiation protection device worn by patients and sometimes dental staff to shield the body from scatter radiation during dental and medical X-ray procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EAJ and the applicable regulation is 21 CFR 892.6500, under the Radiology medical specialty.
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Basic Information
- Product Code
- EAJ
- Device Class
- FDA class 1
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
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 |
|---|---|---|---|---|
| K931269 | LEAD APRON | Jun 02, 1993 | Substantially Equivalent | Bt Medical Co., Inc. |
| K913621 | RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR | Sep 27, 1991 | Substantially Equivalent | Rinn Dental Products |
| K870563 | X-RAY APRON | Feb 19, 1987 | Substantially Equivalent | X-Tech, Ltd. |
| K870103 | LEAD APRON CADDY | Jan 21, 1987 | Substantially Equivalent | Orthopedic Systems, Inc. |
| K832602 | THYROID PROTECTIVE COLLAR | Sep 29, 1983 | Substantially Equivalent | E.M. Adams |
| K832601 | LEADED X-RAY APRON | Sep 29, 1983 | Substantially Equivalent | E.M. Adams |
FEI Numbers
This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.