ELB · Scaler, Rotary
Dental · 21 CFR 872.4840 · Class 2
Overview
| Product Code | ELB |
|---|---|
| Device Name | Scaler, Rotary |
| Regulation | 21 CFR 872.4840 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy.
Classification Rationale
Class II.
Cleared Devices (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170596 | TN-Brush | Genoss Co., Ltd. | Sep 11, 2017 | SESE |
| K121114 | TIGRAN PERIBRUSH | Tigran Technologies AB | Sep 17, 2012 | SESE |
| K111724 | STRAUMANN TIBRUSH | Straumann USA | Sep 12, 2011 | SESE |
| K003640 | MINIENDO III | Sybron Dental Specialties, Inc. | Feb 22, 2001 | SESE |
| K831037 | AIR BURBINE HANDPIECE-DENTAL SCALING | Taco Dental, Inc. | May 9, 1983 | SESE |
| K782007 | ROTARY SCALER | Star Dental Mfg. Co. | Jan 3, 1979 | SESE |
Top Applicants
- Tigran Technologies AB — 1 clearance
- Taco Dental, Inc. — 1 clearance
- Sybron Dental Specialties, Inc. — 1 clearance
- Straumann USA — 1 clearance
- Star Dental Mfg. Co. — 1 clearance
