Manufacturer registered with FDA
Micron Corporation
Ota-ku, Japan. Lists 4 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 10
- 510(k) clearances
- 51999–2018
- Markets registered in
- 415 registrations outside the US
- Establishments
- 1Japan
510(k) clearances per year, 1990–2026
Registered in 4 markets
Where regulators' registries name Micron Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Micron Corporation | 5 clearances | 1999–2018 | Below |
| South Korea | MFDS | Manufacturer | Micron corporationMICRON CORPORATION · MICRON Corporation | 6 | 2009–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Micron CorpMicron Corporation | 5 | 2013–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MICRON CORPORATIONMicron Inc. | 4 | 2011–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Micron Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | AW-100Micron SSSSA-100TA-100TA-200VIP60YU-100YULLY PLUS | 2007 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Quick Jet M | 2014 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | — | 2010 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | M-Tip | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Micron Corporation as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Mar 2018 | K171150 | AW-100 | ELC Ultrasonic Scaler |
| 22 Dec 2016 | K161639 | Y-MIC | ELC Ultrasonic Scaler |
| 28 Mar 2014 | K133170 | QUICK JET M | EFB Dental Air-Powered Handpiece |
| 20 Nov 2003 | K032995 | SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL) | ELC Ultrasonic Scaler |
| 18 Oct 1999 | K991239 | VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2 | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MICRON CORP.FDA reg. 9614726 | OTA-KU Tokyo, Japan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9037104). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.