Scaler, Rotary
The Rotary Scaler is a motor-driven dental instrument that uses a rapidly rotating tip or insert to remove calculus and deposits from tooth surfaces, typically used during prophylaxis and periodontal debridement procedures as an alternative to or in combination with hand instruments. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is ELB, regulated under 21 CFR 872.4840 in the Dental (DE) specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- ELB
- Device Class
- FDA class 2
- Regulation Number
- 872.4840
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K170596 | TN-Brush | Sep 11, 2017 | Substantially Equivalent | Genoss Co., Ltd. |
| K121114 | TIGRAN PERIBRUSH | Sep 17, 2012 | Substantially Equivalent | Tigran Technologies AB |
| K111724 | STRAUMANN TIBRUSH | Sep 12, 2011 | Substantially Equivalent | Straumann USA |
| K003640 | MINIENDO III | Feb 22, 2001 | Substantially Equivalent | Sybron Dental Specialties, Inc. |
| K831037 | AIR BURBINE HANDPIECE-DENTAL SCALING | May 09, 1983 | Substantially Equivalent | Taco Dental, Inc. |
| K782007 | ROTARY SCALER | Jan 03, 1979 | Substantially Equivalent | Star Dental Mfg. Co. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.