Primer-P Adhesive Agent
FDA 510(k) K896719 · Parkell
510(k) numberK896719
Submission
- Device name
- Primer-P Adhesive Agent
- Applicant
- Parkell
Farmingdale, NY, US - Received
- November 29, 1989
- Decision date
- February 22, 1990
- 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 |
|---|---|---|
| K243254 | Parkell Pit and Fissure SealantEBC · Abbreviated | 08/08/2025SE |
| K210259 | Parkell Self-Adhesive CementEMA · Traditional | 01/20/2022SE |
| K191103 | Parkell Desensitizer GelEJK · Traditional | 11/22/2019SE |
| K190930 | SmarTemp X1EBG · Traditional | 09/05/2019SE |
| K182296 | HyperFil-LVEBF · Traditional | 12/14/2018SE |
| K172176 | Parkell Universal AdhesiveKLE · Traditional | 11/21/2017SE |
| K151518 | Brush&Bond PlusKLE · Traditional | 09/18/2015SE |
| K142848 | Eazy PrimerKLE · Traditional | 02/24/2015SE |
| K132115 | Absolute Dentin 2EBF · Traditional | 06/25/2014SE |
| K113839 | Retract Gingival Retraction/Hemostatic PasteMVL · Traditional | 04/12/2012SE |
Questions and answers
When was Primer-P Adhesive Agent cleared by the FDA?
Primer-P Adhesive Agent (K896719) received a 510(k) decision of Substantially Equivalent on February 22, 1990, 85 days after the submission was received.
What is the product code of K896719?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.