Denture Resin
FDA 510(k) K890830 · G-C Intl. Corp.
510(k) numberK890830
Submission
- Device name
- Denture Resin
- Applicant
- G-C Intl. Corp.
Scottsdale, AZ, US - Received
- February 21, 1989
- Decision date
- May 1, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261802 | Glidewell Denture Base ResinEBI · Traditional | Prismatik Dentalcraft, Inc. | 08/27/2026SE |
| K261626 | UltraPrint Flexible Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 08/13/2026SE |
| K262681 | NanoCeram ResinEBI · Traditional | 3BFAB Teknoloji A.S. | 07/31/2026SE |
| K262300 | Denture Base Resin V2EBI · Abbreviated | Formlabs Ohio, Inc. | 07/08/2026SE |
| K261474 | DENTCA Tru FlexibleEBI · Traditional | Dentca, Inc. | 07/01/2026SE |
| K260569 | DB 4000 High Impact Denture BaseEBI · Abbreviated | Carbon, Inc. | 06/02/2026SE |
| 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 |
| K253324 | UltraPrint-Dental Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 11/20/2025SE |
More from Guangzhou Heygears IMC., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K913175 | Miracle Mix Caps Glass Ionomer Cement IncapsulesEJJ · Traditional | 12/27/1991SE |
| K913884 | Fuji II LCEMA · Traditional | 10/30/1991SE |
| K901999 | Fuji Lining Cement Light CureEJK · Traditional | 07/31/1990SE |
| K902531 | Exaphase, Single Phase Impression MaterialEGW · Traditional | 07/13/1990SE |
| K896883 | GC Cervical CementEMA · Traditional | 07/06/1990SE |
| K895976 | Tooth Shade ResinEBF · Traditional | 12/22/1989SE |
| K892806 | Tuf-CoatELL · Traditional | 07/14/1989SE |
| K890829 | Unifast LCEBG · Traditional | 04/17/1989SE |
| K883770 | Resubmitted Ema Dentin CementEMA · Traditional | 11/30/1988SE |
| K880848 | Fuji Cap II Capsule & ApplierEMA · Traditional | 05/16/1988SE |
Questions and answers
When was Denture Resin cleared by the FDA?
Denture Resin (K890830) received a 510(k) decision of Substantially Equivalent on May 1, 1989, 69 days after the submission was received.
What is the product code of K890830?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.