Nexus Universal, Nexus Universal Chroma
FDA 510(k) K151332 · Sybron Dental Specialties
510(k) numberK151332
Submission
- Device name
- Nexus Universal, Nexus Universal Chroma
- Applicant
- Sybron Dental Specialties
Orange, CA, US - Received
- May 19, 2015
- Decision date
- August 17, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EMA
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| 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 |
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| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressKIF · Traditional | 07/27/2016SE |
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| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesKIF · Special | 04/14/2016SE |
| K151526 | Zone, ZoneFree, Zone A1EMA · Traditional | 09/10/2015SE |
| K150559 | Life Fast Set, Life Regular SetEJK · Special | 06/19/2015SE |
| K143209 | SonicFill 2EBF · Traditional | 02/05/2015SE |
| K130869 | Take 1 AdvanceELW · Traditional | 05/30/2013SE |
Questions and answers
When was Nexus Universal, Nexus Universal Chroma cleared by the FDA?
Nexus Universal, Nexus Universal Chroma (K151332) received a 510(k) decision of Substantially Equivalent on August 17, 2015, 90 days after the submission was received.
What is the product code of K151332?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.