Condenser, Amalgam And Foil, Operative
The Amalgam and Foil Condenser is a dental hand instrument used to pack and consolidate dental amalgam or gold foil into the prepared cavity, eliminating voids and ensuring adequate adaptation of the restorative material to the cavity walls. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKG, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EKG
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K865025 | AUSTENAL CONDENSING INSTRUMENT | Feb 19, 1987 | Substantially Equivalent | Austenal Dental, Inc. |
| K843901 | ISOSTATIC CONDENSER | Dec 03, 1984 | Substantially Equivalent | Shofu Dental Corp. |
| K823322 | DENTAL INSTRUMENTS - PLUGGERS | Nov 24, 1982 | Substantially Equivalent | Miltex, Inc. |
FEI Numbers
This FDA classification entry is associated with 56 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 56 registration numbers. Click on an entry to view related FDA registrations.