Life Fast Set, Life Regular Set
FDA 510(k) K150559 · Sybron Dental Specialties
510(k) numberK150559
Submission
- Device name
- Life Fast Set, Life Regular Set
- Applicant
- Sybron Dental Specialties
Orange, CA, US - Received
- March 6, 2015
- Decision date
- June 19, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K141047 | LC Calciumhydroxide LinerEJK · Traditional | S&C Polymer Silicon- Und Composite Spezialitaeten | 04/14/2015SE |
More from S&C Polymer Silicon- Und Composite Spezialitaeten
| 510(k) | Device | Decision |
|---|---|---|
| K182826 | Ormco Spark Aligner SystemNXC · Traditional | 10/11/2018SE |
| K162063 | Steri-Cassette and Steri-Cage Sterilization Packaging SystemKCT · Traditional | 04/21/2017SE |
| K160097 | Image Fast Set, Image Regular SetELW · Traditional | 08/05/2016SE |
| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressKIF · Traditional | 07/27/2016SE |
| K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWTKIF · Traditional | 05/06/2016SE |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesKIF · Special | 04/14/2016SE |
| K151526 | Zone, ZoneFree, Zone A1EMA · Traditional | 09/10/2015SE |
| K151332 | Nexus Universal, Nexus Universal ChromaEMA · Abbreviated | 08/17/2015SE |
| K143209 | SonicFill 2EBF · Traditional | 02/05/2015SE |
| K130869 | Take 1 AdvanceELW · Traditional | 05/30/2013SE |
Questions and answers
When was Life Fast Set, Life Regular Set cleared by the FDA?
Life Fast Set, Life Regular Set (K150559) received a 510(k) decision of Substantially Equivalent on June 19, 2015, 105 days after the submission was received.
What is the product code of K150559?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.