Summar Non-Precious, Ceramic Alloy
FDA 510(k) K811013 · Shofu Dental Corp.
510(k) numberK811013
Submission
- Device name
- Summar Non-Precious, Ceramic Alloy
- Applicant
- Shofu Dental Corp.
Mchenry, IL, US - Received
- April 15, 1981
- Decision date
- June 26, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123929 | Begopal+EJH · Abbreviated | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 03/14/2013SE |
| K040180 | Continum VEJH · Traditional | Aalba Dent, Inc. | 03/04/2004SE |
| K040179 | ContinumEJH · Traditional | Aalba Dent, Inc. | 03/03/2004SE |
| K033356 | Verasoft EsEJH · Traditional | Aalba Dent, Inc. | 12/30/2003SE |
| K033045 | Dream Bond, Dreamcast Chrome, Dreamcast V, Dream Flexicast, Dream LithecastEJH · Traditional | American Green Dent. Mfg, Inc. | 12/23/2003SE |
| K032136 | Wirobond CEJH · Traditional | Bego U.S.A. | 09/04/2003SE |
| K031627 | Nano-TicrownEJH · Traditional | Nano-Write Corp. | 06/11/2003SE |
| K030632 | PD Casta-HEJH · Traditional | Mountain Medico, Inc. | 05/07/2003SE |
| K030416 | Ceracast-VEJH · Traditional | Mountain Medico, Inc. | 04/14/2003SE |
| K030161 | SuperbondEJH · Traditional | American Dent-All, Inc. | 03/17/2003SE |
More from American Dent-All, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252808 | GlasIonomer FX-LCEMA · Traditional | 12/09/2025SE |
| K252165 | Zirconomer PEMA · Traditional | 10/28/2025SE |
| 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 Summar Non-Precious, Ceramic Alloy cleared by the FDA?
Summar Non-Precious, Ceramic Alloy (K811013) received a 510(k) decision of Substantially Equivalent on June 26, 1981, 72 days after the submission was received.
What is the product code of K811013?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.