Photac-Bond
FDA 510(k) K904096 · Espe GmbH (Us)
510(k) numberK904096
Submission
- Device name
- Photac-Bond
- Applicant
- Espe GmbH (Us)
Lake Worth, FL, US - Received
- September 6, 1990
- Decision date
- November 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261728 | One-Fil LCEJK · Traditional | Mediclus Co., Ltd. | 07/21/2026SE |
| K253248 | Bright Cavity LinerEJK · Traditional | Dmp Dental Industry S.A. | 01/13/2026SE |
| K230270 | 3M VitCal Liner/BaseEJK · Traditional | 3M Espe Dental Products | 02/06/2023SE |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)EJK · Traditional | Prevest Denpro Limited | 05/13/2022SE |
| K201799 | CleaniCalEJK · Traditional | Maruchi | 02/12/2021SE |
| K202413 | LC ResinCal PCEJK · Traditional | S&C Polymer Silicon- Und Composite Spezialitaten… | 11/20/2020SE |
| K191103 | Parkell Desensitizer GelEJK · Traditional | Parkell, Inc. | 11/22/2019SE |
| K180344 | TheraCal DCEJK · Special | Bisco, Inc. | 04/05/2018SE |
| K143292 | TheraCal DCEJK · Traditional | Bisco, Inc. | 08/04/2015SE |
| K150559 | Life Fast Set, Life Regular SetEJK · Special | Sybron Dental Specialties | 06/19/2015SE |
More from Sybron Dental Specialties
| 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 |
| K913965 | Espe(R) -SilKLE · Traditional | 12/04/1991SE |
| K905604 | Visio-Gem Art-SystemEBF · Traditional | 03/29/1991SE |
| 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 Photac-Bond cleared by the FDA?
Photac-Bond (K904096) received a 510(k) decision of Substantially Equivalent on November 19, 1990, 74 days after the submission was received.
What is the product code of K904096?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.