Scaler, Periodontic
The periodontic scaler is a dental instrument used to remove calculus and plaque deposits from the surfaces of teeth, particularly below the gumline, during periodontal maintenance procedures. It is classified as FDA Class 1, indicating it requires only general controls and no premarket notification. The product code is EMN, regulated under 21 CFR 872.4565 in the Dental specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- EMN
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070127 | PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 | Mar 29, 2007 | Substantially Equivalent | Kevin Vu, Dds |
| K931330 | DENTAL INSTRUMENTS SCALER | Jan 26, 1994 | Substantially Equivalent | Minnesota Prophy Power, Inc. |
| K851721 | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | Jul 02, 1985 | Substantially Equivalent | Artiberia |
| K821786 | BEACH SCALERS | Jul 06, 1982 | Substantially Equivalent | Pacific Dental Corp. |
| K781035 | PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX | Jun 30, 1978 | Substantially Equivalent | Premier Dental Products Co. |
FEI Numbers
This FDA classification entry is associated with 213 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 213 registration numbers. Click on an entry to view related FDA registrations.