Instrument, Hand, Calculus Removal
The Hand Calculus Removal Instrument is a manual dental scaling instrument such as a sickle scaler or curette used by dental hygienists and dentists to manually detect and remove supragingival and subgingival calculus deposits from tooth surfaces during periodontal therapy. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is ELA, regulated under 21 CFR 872.4565 in the Dental (DE) specialty.
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Basic Information
- Product Code
- ELA
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K952363 | OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) | Aug 15, 1995 | Substantially Equivalent | Ela Medical, Inc. |
| K854168 | TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES | Mar 13, 1986 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K823326 | DENTAL INSTRUMENTS - CUTTING INSTRUMENT | Nov 24, 1982 | Substantially Equivalent | Miltex, Inc. |
| K801974 | ANALYTIC TECH. METAL POINT HEATER #3001 | Nov 12, 1980 | Substantially Equivalent | Analytic Technology |
FEI Numbers
This FDA classification entry is associated with 62 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 62 registration numbers. Click on an entry to view related FDA registrations.