Fuji II LC
FDA 510(k) K913884 · G-C Intl. Corp.
510(k) numberK913884
Submission
- Device name
- Fuji II LC
- Applicant
- G-C Intl. Corp.
Scottsdale, AZ, US - Received
- August 29, 1991
- Decision date
- October 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EMA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254201 | Any-CemEMA · Traditional | Mediclus Co., Ltd. | 08/13/2026SE |
| K261937 | PacTemp Automix NEEMA · Traditional | The Belport Company Inc., DBA Gingi-Pak | 08/07/2026SE |
| K261166 | Dia-CemEMA · Traditional | DiaDent Group International | 07/09/2026SE |
| K254109 | G-Cem UniversalEMA · Traditional | GC America, Inc. | 05/18/2026SE |
| K253337 | REGEN Bioactive CementEMA · Traditional | Inter-Med, Inc. | 04/15/2026SE |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-InEMA · Traditional | Voco GmbH | 03/20/2026SE |
| K254063 | iCEM Universal PlusEMA · Abbreviated | Kulzer, LLC | 12/19/2025SE |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin CementEMA · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/12/2025SE |
| K252808 | GlasIonomer FX-LCEMA · Traditional | Shofu Dental Corporation | 12/09/2025SE |
| K252165 | Zirconomer PEMA · Traditional | Shofu Dental Corporation | 10/28/2025SE |
More from Shofu Dental Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K913175 | Miracle Mix Caps Glass Ionomer Cement IncapsulesEJJ · Traditional | 12/27/1991SE |
| K901999 | Fuji Lining Cement Light CureEJK · Traditional | 07/31/1990SE |
| K902531 | Exaphase, Single Phase Impression MaterialEGW · Traditional | 07/13/1990SE |
| K896883 | GC Cervical CementEMA · Traditional | 07/06/1990SE |
| K895976 | Tooth Shade ResinEBF · Traditional | 12/22/1989SE |
| K892806 | Tuf-CoatELL · Traditional | 07/14/1989SE |
| K890830 | Denture ResinEBI · Traditional | 05/01/1989SE |
| K890829 | Unifast LCEBG · Traditional | 04/17/1989SE |
| K883770 | Resubmitted Ema Dentin CementEMA · Traditional | 11/30/1988SE |
| K880848 | Fuji Cap II Capsule & ApplierEMA · Traditional | 05/16/1988SE |
Questions and answers
When was Fuji II LC cleared by the FDA?
Fuji II LC (K913884) received a 510(k) decision of Substantially Equivalent on October 30, 1991, 62 days after the submission was received.
What is the product code of K913884?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.