Clamp, Rubber Dam
The Rubber Dam Clamp is a dental device, typically made from metal, that is placed around a tooth to anchor the rubber dam in position during dental procedures, isolating the tooth from the oral environment to maintain a dry, clean working field. It is classified as FDA Class 1, the lowest risk category, and is GMP exempt, meaning it is also exempt from most good manufacturing practice requirements. The product code is EEF and the applicable regulation is 21 CFR 872.6300, under the Dental medical specialty.
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Basic Information
- Product Code
- EEF
- 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 |
|---|---|---|---|---|
| K071615 | FIXAFLOSS | Sep 21, 2007 | Substantially Equivalent | Sybron Dental Specialties, Inc. |
| K915207 | DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP | Feb 14, 1992 | Substantially Equivalent | Bay Technical Products, Inc. |
| K780744 | BRINKER TISSUE RETRACTORS | May 12, 1978 | Substantially Equivalent | Hygienic Dental Mfg., Co., The |
FEI Numbers
This FDA classification entry is associated with 93 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 93 registration numbers. Click on an entry to view related FDA registrations.