LC CALCIUMHYDROXIDE LINER
FDA 510(k) clearance K141047 · decided 2015-04-14
Clearance details
- K-number
- K141047
- Device name
- LC CALCIUMHYDROXIDE LINER
- Applicant
- S&C Polymer Silicon- Und Composite Spezialitaeten
- Decision
- Substantially Equivalent
- Date received
- 2014-04-23
- Decision date
- 2015-04-14
- Days to decision
- 356 days
- Clearance type
- Traditional
- Product code
- EJK
- Device class
- 2
- Regulation number
- 872.3250
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Elmshorn, Schleswig-Holstein, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| One-Fil LC (K261728) | Mediclus Co., Ltd. | 2026-07-21 |
| Bright Cavity Liner (K253248) | Dmp Dental Industry S.A. | 2026-01-13 |
| 3M™ VitCal Liner/Base (K230270) | 3M Espe Dental Products | 2023-02-06 |
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| CleaniCal (K201799) | Maruchi | 2021-02-12 |
| LC ResinCal PC (K202413) | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | 2020-11-20 |
| Parkell Desensitizer Gel (K191103) | Parkell, Inc. | 2019-11-22 |
| TheraCal DC (K180344) | Bisco, Inc. | 2018-04-05 |
| TheraCal DC (K143292) | Bisco, Inc. | 2015-08-04 |
| Life Fast Set, Life Regular Set (K150559) | Sybron Dental Specialties | 2015-06-19 |
| BASE IT (K134022) | Spident Co., Ltd. | 2014-06-11 |
| TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID (K131068) | Kuraray Noritake Dental, Inc. | 2013-08-27 |
Recalls involving this device
No recalls on record reference this clearance.