Set
FDA 510(k) K051008 · Southern Dental Industries, Ltd.
510(k) numberK051008
Submission
- Device name
- Set
- Applicant
- Southern Dental Industries, Ltd.
Bensenville, IL, US - Received
- April 20, 2005
- Decision date
- June 15, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K062065 | Riva Luting PlusEMA · Traditional | 11/15/2006SE |
| K062064 | Riva Bond LCEMA · Traditional | 11/09/2006SE |
| K050871 | Riva ProtectEBC · Traditional | 06/10/2005SE |
| K050870 | Riva Light CureEMA · Traditional | 06/03/2005SE |
| K050331 | Adhesive 1KLE · Traditional | 03/24/2005SE |
| K042452 | Riva SilverEMA · Traditional | 12/07/2004SE |
| K040393 | Riva LutingEMA · Traditional | 04/30/2004SE |
| K032152 | Benco AdmixEJJ · Traditional | 08/06/2003SE |
| K031658 | Benco SphericalEJJ · Traditional | 07/29/2003SE |
| K030568 | RadiiEBZ · Traditional | 04/24/2003SE |
Questions and answers
When was Set cleared by the FDA?
Set (K051008) received a 510(k) decision of Substantially Equivalent on June 15, 2005, 56 days after the submission was received.
What is the product code of K051008?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.