Frame, Rubber Dam
The Rubber Dam Frame is a rigid support structure, typically made of metal or plastic, onto which the rubber dam sheet is stretched and secured, maintaining tension across the oral cavity to provide effective field isolation during dental procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EJE, regulated under 21 CFR 872.6300 in the Dental (DE) specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- EJE
- Device Class
- FDA class 1
- Regulation Number
- 872.6300
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K781520 | RUBBER DAM HOLDER | Oct 10, 1978 | Substantially Equivalent | Young Dental Manufacturing Co. 1, LLC |
| K780746 | HYGIENIC RUBBER DAM FRAME | May 12, 1978 | Substantially Equivalent | Hygienic Dental Mfg., Co., The |
| K770117 | HYGIENIC 5 & 6 RUBBER DAM FRAME | Jan 28, 1977 | Substantially Equivalent | Hygienic Dental Mfg., Co., The |
FEI Numbers
This FDA classification entry is associated with 59 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 59 registration numbers. Click on an entry to view related FDA registrations.