Lime-Lite II
FDA 510(k) K113711 · Pulpdent Corporation
510(k) numberK113711
Submission
- Device name
- Lime-Lite II
- Applicant
- Pulpdent Corporation
Watertown, MA, US - Received
- December 19, 2011
- Decision date
- March 5, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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| K153249 | Pulpdent Solo Flowable Composite with MCPEBF · Traditional | 04/01/2016SE |
| K130223 | Rmgi FillEMA · Traditional | 03/29/2013SE |
| K123265 | Rmgi Low ViscosityEMA · Traditional | 12/07/2012SE |
| K120784 | Tuff-Temp 2.0EBG · Traditional | 06/08/2012SE |
| K120003 | NucalEJK · Traditional | 04/05/2012SE |
| K120213 | Etch-Rite SupremeKLE · Traditional | 03/30/2012SE |
| K113818 | Embrace Wetbond Pit and Fissure Sealant, Low FillEBC · Traditional | 03/21/2012SE |
Questions and answers
When was Lime-Lite II cleared by the FDA?
Lime-Lite II (K113711) received a 510(k) decision of Substantially Equivalent on March 5, 2012, 77 days after the submission was received.
What is the product code of K113711?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.