Espe(R) -Sil
FDA 510(k) K913965 · Espe GmbH (Us)
510(k) numberK913965
Submission
- Device name
- Espe(R) -Sil
- Applicant
- Espe GmbH (Us)
West Germany, DE - Received
- September 5, 1991
- Decision date
- December 4, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KLE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260485 | Any-EtchKLE · Traditional | Mediclus Co., Ltd. | 05/14/2026SE |
| K260430 | Porcelain Etch GelKLE · Traditional | Belport Company, Inc., Gingi-Pak | 04/10/2026SE |
| K252450 | Adhese 2KLE · Traditional | Ivoclar Vivadent, Inc. | 03/05/2026SE |
| 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 |
More from Rizhao Huge Biomaterials Company, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K925027 | Photac-Fil AplicapEMA · Traditional | 06/18/1993SE |
| K915005 | Photac-Bond Aplicap, ModificationEMA · Traditional | 01/14/1992SE |
| K913966 | Sono(R) -CemEBF · Traditional | 01/14/1992SE |
| K913857 | Rocatec(R) -PlusEJH · Traditional | 12/16/1991SE |
| K905604 | Visio-Gem Art-SystemEBF · Traditional | 03/29/1991SE |
| K904096 | Photac-BondEJK · Traditional | 11/19/1990SE |
| K904097 | Photac-Bond AplicapEJK · Traditional | 11/09/1990SE |
| K904289 | Pertac Universal BondKLE · Traditional | 11/01/1990SE |
| K900510 | Pertac-HybridEBF · Traditional | 08/09/1990SE |
| K900558 | Pertac BondKLE · Traditional | 04/10/1990SE |
Questions and answers
When was Espe(R) -Sil cleared by the FDA?
Espe(R) -Sil (K913965) received a 510(k) decision of Substantially Equivalent on December 4, 1991, 90 days after the submission was received.
What is the product code of K913965?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.