FDA product code ELB: Scaler, Rotary
ELB is the FDA product code for scaler, rotary. It is a Class II device, regulated under 21 CFR 872.4840 and reviewed by the Dental panel. FDA has cleared 6 510(k) submissions under ELB, from 6 different applicants. The average 510(k) review took 99 days (median 86).
Classification
| Field | Value |
|---|---|
| Device name | Scaler, Rotary |
| Device class | Class II |
| Regulation | 21 CFR 872.4840 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ELB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 195 |
Compare with all 510(k) review times · Search every ELB clearance
Top ELB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Genoss Co., Ltd. | 1 | 2017-09-11 |
| Tigran Technologies AB | 1 | 2012-09-17 |
| Straumann USA | 1 | 2011-09-12 |
| Sybron Dental Specialties, Inc. | 1 | 2001-02-22 |
| Taco Dental, Inc. | 1 | 1983-05-09 |
1 more applicants have ELB clearances. See the full list in Caduvo.
Most recent ELB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170596 | Genoss Co., Ltd. | TN-Brush | 2017-09-11 | 195 |
| K121114 | Tigran Technologies AB | TIGRAN PERIBRUSH | 2012-09-17 | 158 |
| K111724 | Straumann USA | STRAUMANN TIBRUSH | 2011-09-12 | 84 |
| K003640 | Sybron Dental Specialties, Inc. | MINIENDO III | 2001-02-22 | 87 |
| K831037 | Taco Dental, Inc. | AIR BURBINE HANDPIECE-DENTAL SCALING | 1983-05-09 | 39 |
Recalls for ELB devices
openFDA lists no recalls for product code ELB.
Frequently asked questions
What is FDA product code ELB?
ELB is the FDA product code for scaler, rotary. It is a Class II device, regulated under 21 CFR 872.4840 and reviewed by the Dental panel.
What device class is ELB?
Class II, regulation 21 CFR 872.4840. Typical premarket route: 510(k).
How long does a 510(k) take for product code ELB?
Across 6 cleared submissions the average was 99 days from receipt to decision (median 86).
Which companies have the most ELB clearances?
Genoss Co., Ltd. (1); Tigran Technologies AB (1); Straumann USA (1); Sybron Dental Specialties, Inc. (1); Taco Dental, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ELB
- Run a recall and safety report across every ELB manufacturer
- Watch product code ELB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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