510(k) K024198
- Device
- SMEARCLEAR
- Applicant
- SYBRON DENTAL SPECIALTIES, INC.
- 510(k) number
- K024198
- Product code
- KJJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-03-05
- Date received
- 2002-12-20
- Regulation
- 510(k) Premarket Notification
- Classification name
- Cleanser, Root Canal
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Dental
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- COLLEEN BOSWELL
- Address
- 1717 W. Collins Ave. Orange CA US 92867 92867
FDA Registration Numbers#
- 1032227
- 2024024
- 1941138
- 3009603151
- 3004554409
- 3042866301
- 2511556
- 9680845
- 1413475
- 2320721
- 2024980
- 1223843
- 3038718579
- 3003428492
- 3028011
- 2086043
- 3007244484
- 2433629
- 3010864832
- 3026760
- 2245590
- 3005941719
- 3006444232
- 2437780
- 3012187973
- 2133714
- 2515379
- 9612827
- 3012477813
- 3012421607
- 9613348
- 1718912
- 2024312
- 2416455
- 3027344570
Source Documents#
Other 510(k) Records For Product Code KJJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250279 | RC-SwiftPrep | Belport Company, Inc., Gingi-Pak | 2025-07-02 |
| K241354 | Sealer Solvent | Inter-Med, Inc. | 2024-08-27 |
| K201785 | EPIEN Dental Cleanser | Epien Medical, Inc. | 2021-09-09 |
| K211813 | Triton | Inter-Med / Vista Dental | 2021-08-18 |
| K193357 | V-Mix | Inter-Med/Vista Dental Products | 2020-10-23 |
| K193409 | Vista Rinse, Vista Rinse Plus | Inter-Med/Vista Dental Products | 2020-09-09 |
| K200330 | RC-Prime Root Canal Preparation Cream | Pac-Dent, Inc. | 2020-07-06 |
| K173163 | ChlorCid, ChlorCid V, ChlorCid Surf | Ultradent Products, Inc. | 2018-02-09 |
| K162311 | Straumann PrefGel | Institut Straumann AG | 2017-03-07 |
| K160577 | PacEndo Chlorhexidine | Pac-Dent International, Inc. | 2016-07-25 |
| K153528 | PacEndo EDTA | Pac-Dent International, Inc. | 2016-02-01 |
| K151852 | PacEndo Sodium Hyprochlorite | Pac-Dent International, Inc. | 2015-11-10 |
| K150020 | Irritrol, EDS Combo-Rinse | Essential Dental Systesm, Inc. | 2015-02-25 |
| K141352 | ENDOCYN ROOT CANAL IRRIGATION SOLUTION | Oculus Innovative Sciences | 2014-08-18 |
| K140846 | EDS COMBO-RINSE | Essential Dental Systems, Inc. | 2014-07-25 |
Legacy Summary#
summary
FDA Review#
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