Unit, Suction Operatory
The Operatory Suction Unit is a dental device that provides the high-volume vacuum suction used at the chairside to remove saliva, blood, water, and debris from the oral cavity during dental treatment, keeping the field clear and dry. 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 EBR and the applicable regulation is 21 CFR 872.6640, under the Dental medical specialty.
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Basic Information
- Product Code
- EBR
- Device Class
- FDA class 1
- Regulation Number
- 872.6640
- 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 |
|---|---|---|---|---|
| K925367 | A-DEC 7284 CUSPIDOR, CASCADE | Apr 11, 1994 | Substantially Equivalent | A-Dec, Inc. |
| K860058 | DENPAX | Mar 12, 1986 | Substantially Equivalent | Nissho Iwai American Corp. |
| K770600 | OROPHARYNGEAL SUCTION AIRWAY | Apr 08, 1977 | Substantially Equivalent | W.H. Wall, D.D.S. |
FEI Numbers
This FDA classification entry is associated with 73 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 73 registration numbers. Click on an entry to view related FDA registrations.