Connect
FDA 510(k) K900303 · Parkell
510(k) numberK900303
Submission
- Device name
- Connect
- Applicant
- Parkell
Farmingdale, NY, US - Received
- January 22, 1990
- Decision date
- April 12, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K243254 | Parkell Pit and Fissure SealantEBC · Abbreviated | 08/08/2025SE |
| K210259 | Parkell Self-Adhesive CementEMA · Traditional | 01/20/2022SE |
| K191103 | Parkell Desensitizer GelEJK · Traditional | 11/22/2019SE |
| K190930 | SmarTemp X1EBG · Traditional | 09/05/2019SE |
| K182296 | HyperFil-LVEBF · Traditional | 12/14/2018SE |
| K172176 | Parkell Universal AdhesiveKLE · Traditional | 11/21/2017SE |
| K151518 | Brush&Bond PlusKLE · Traditional | 09/18/2015SE |
| K142848 | Eazy PrimerKLE · Traditional | 02/24/2015SE |
| K132115 | Absolute Dentin 2EBF · Traditional | 06/25/2014SE |
| K113839 | Retract Gingival Retraction/Hemostatic PasteMVL · Traditional | 04/12/2012SE |
Questions and answers
When was Connect cleared by the FDA?
Connect (K900303) received a 510(k) decision of Substantially Equivalent on April 12, 1990, 80 days after the submission was received.
What is the product code of K900303?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.