Dinabase (TM)
FDA 510(k) K971138 · Sultan Chemists, Inc.
510(k) numberK971138
Submission
- Device name
- Dinabase (TM)
- Applicant
- Sultan Chemists, Inc.
Englewood, NJ, US - Received
- March 28, 1997
- Decision date
- July 21, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K052699 | Versa-Link Porcelain Bonding SystemKLE · Traditional | 11/16/2005SE |
| K052409 | Silgimix Alginate Replacement Impression MaterialELW · Traditional | 10/20/2005SE |
| K043054 | Genie Magic Mix Ultra Hydrophilic Impression MaterialELW · Traditional | 02/18/2005SE |
| K030414 | Genie Ultra Hydrophilic Impression MaterialELW · Traditional | 04/09/2003SE |
| K020612 | Sultan Sporox Test Vial, Model 75195JOJ · Traditional | 05/07/2002SE |
| K002843 | Sultan Sensitemp Resin Temporary Cement, Model 70010EMA · Traditional | 11/15/2000SE |
| K991509 | Pro-Portion Cleaner/DisinfectantLRJ · Traditional | 07/14/1999SE |
| K951590 | Assure, Self-Sealing Sterilization PouchKCT · Traditional | 05/17/1995SE |
| K933729 | Assure Self Sealing Sterilization PouchKCT · Traditional | 06/21/1994SE |
| K896826 | Sultan Perio-Select Irrigation System · Traditional | 03/02/1990SEKD |
Questions and answers
When was Dinabase (TM) cleared by the FDA?
Dinabase (TM) (K971138) received a 510(k) decision of Substantially Equivalent on July 21, 1997, 115 days after the submission was received.
What is the product code of K971138?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.