510(k) K021146
- Device
- D/SENSE 1-STEP
- Applicant
- CENTRIX, INC.
- 510(k) number
- K021146
- Product code
- EJK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-07-02
- Date received
- 2002-04-09
- Regulation
- 872.3250
- Classification name
- Liner, Cavity, Calcium Hydroxide
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN DISCKO
- Address
- 770 River Rd. Shelton CT US 06484 06484
FDA Registration Numbers#
- 3002807050
- 3005176727
- 3010407924
- 8020994
- 3032312561
- 3002807420
- 3005628474
- 8030938
- 3006113314
- 1000492377
- 1215305
- 1281412
- 3032911850
- 9611385
- 1420052
- 2219920
- 9612300
- 8010908
- 3003120666
- 3009560600
- 3031841433
- 2022039
- 3038718579
- 2429849
- 2411797
- 9681210
- 3032163716
- 2241860
- 2433629
- 3012322979
- 3016447764
- 3008966075
- 3006444232
- 3012187973
- 3042272797
- 2515379
- 3012996495
- 3012494290
- 3035693034
- 3012421607
- 9680144
- 1718912
- 3004569445
- 2024312
- 3043226252
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EJK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253248 | Bright Cavity Liner | Dmp Dental Industry S.A. | 2026-01-13 |
| K230270 | 3M™ VitCal Liner/Base | 3M Espe Dental Products | 2023-02-06 |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | Prevest Denpro Limited | 2022-05-13 |
| K201799 | CleaniCal | Maruchi | 2021-02-12 |
| K202413 | LC ResinCal PC | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | 2020-11-20 |
| K191103 | Parkell Desensitizer Gel | Parkell, Inc. | 2019-11-22 |
| K180344 | TheraCal DC | Bisco, Inc. | 2018-04-05 |
| K143292 | TheraCal DC | Bisco, Inc. | 2015-08-04 |
| K150559 | Life Fast Set, Life Regular Set | Sybron Dental Specialties | 2015-06-19 |
| K141047 | LC CALCIUMHYDROXIDE LINER | S&C Polymer Silicon- Und Composite Spezialitaeten | 2015-04-14 |
| K134022 | BASE IT | Spident Co., Ltd. | 2014-06-11 |
| K131068 | TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID | Kuraray Noritake Dental, Inc. | 2013-08-27 |
| K122421 | TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID | Kuraray Noritake Dental, Inc. | 2012-12-11 |
| K120003 | NUCAL | Pulpdent Corporation | 2012-04-05 |
| K113711 | LIME-LITE II | Pulpdent Corporation | 2012-03-05 |
Legacy Summary#
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FDA Review#
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