Diamond D High Impact Denture Acrylic
FDA 510(k) K032773 · Mycone Dental Supply Co., Inc.
510(k) numberK032773
Submission
- Device name
- Diamond D High Impact Denture Acrylic
- Applicant
- Mycone Dental Supply Co., Inc.
Cherry Hill, NJ, US - Received
- September 8, 2003
- Decision date
- September 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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| K260376 | Denture BaseEBI · Traditional | Shandong Huge Dental Material Corporation | 05/06/2026SE |
| K253365 | LuxCreo Flexible Partial Denture ResinEBI · Traditional | LuxCreo, Inc. | 11/25/2025SE |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard…EBI · Traditional | Graphy, Inc. | 11/21/2025SE |
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Questions and answers
When was Diamond D High Impact Denture Acrylic cleared by the FDA?
Diamond D High Impact Denture Acrylic (K032773) received a 510(k) decision of Substantially Equivalent on September 23, 2003, 15 days after the submission was received.
What is the product code of K032773?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.