BeautiBond Universal
FDA 510(k) K180803 · Shofu Dental Corporation
510(k) numberK180803
Submission
- Device name
- BeautiBond Universal
- Applicant
- Shofu Dental Corporation
San Marcos, CA, US - Received
- March 28, 2018
- Decision date
- September 26, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Rizhao Huge Biomaterials Company, Ltd.
| 510(k) | Device | Decision |
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| K252808 | GlasIonomer FX-LCEMA · Traditional | 12/09/2025SE |
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| K251470 | ResiCem EXEMA · Traditional | 07/11/2025SE |
| K251578 | Beautifil IIEBF · Traditional | 05/27/2025SE |
| K233161 | BeautiLink SAEMA · Traditional | 09/28/2023SE |
| K222253 | GlasIonomer FX ULTRAEMA · Traditional | 09/22/2022SE |
| K213965 | BeautiBond XtremeKLE · Traditional | 03/18/2022SE |
| K212939 | Vintage Prime PressEIH · Traditional | 03/18/2022SE |
| K200470 | Shofu Block HC HardEBF · Traditional | 02/05/2021SE |
| K191794 | Vintage Art UniversalEIH · Traditional | 10/03/2019SE |
Questions and answers
When was BeautiBond Universal cleared by the FDA?
BeautiBond Universal (K180803) received a 510(k) decision of Substantially Equivalent on September 26, 2018, 182 days after the submission was received.
What is the product code of K180803?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.