Modification to Prompt L-Pop
FDA 510(k) K001494 · Espe Dental AG
510(k) numberK001494
Submission
- Device name
- Modification to Prompt L-Pop
- Applicant
- Espe Dental AG
Bavaria D-82228 Seefeld, DE - Received
- May 12, 2000
- Decision date
- July 7, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260682 | Bond-PR Universal AdhesiveKLE · Traditional | Premier Dental Products Company | 03/03/2026SE |
| K251587 | VITA VMLC PrimerKLE · Traditional | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 02/23/2026SE |
| K252151 | els unibondKLE · Traditional | Saremco Dental AG | 12/05/2025SE |
| K252469 | Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional | Dmp Dental Industry S.A. | 11/06/2025SE |
| K251124 | G-Bond UniversalKLE · Traditional | GC America, Inc. | 10/02/2025SE |
| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/20/2024SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 11/08/2024SE |
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| K002364 | Protemp HEBG · Special | 08/10/2000SE |
| K000595 | Dimension Penta LELW · Traditional | 04/05/2000SE |
| K000591 | Dimension Penta H, Dimension Penta H QuickELW · Traditional | 03/30/2000SE |
| K000588 | Dimension Garant L, Dimension Garant L QuickELW · Traditional | 03/30/2000SE |
| K994193 | Impregum Penta DuosoftELW · Traditional | 01/28/2000SE |
| K994192 | Impregum Penta M MonosoftELW · Traditional | 01/28/2000SE |
| K994190 | Impregum Garant L DuosoftELW · Traditional | 01/27/2000SE |
Questions and answers
When was Modification to Prompt L-Pop cleared by the FDA?
Modification to Prompt L-Pop (K001494) received a 510(k) decision of Substantially Equivalent on July 7, 2000, 56 days after the submission was received.
What is the product code of K001494?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.