510(k) K112508
- Device
- I-ROOT 100
- Applicant
- S-DENTI CO., LTD.
- 510(k) number
- K112508
- Product code
- LQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-06-19
- Date received
- 2011-08-30
- Regulation
- 510(k) Premarket Notification
- Classification name
- Locator, Root Apex
- 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
- TAE K NAM
- Address
- Valley 6,481-4 Gasan-Dong Geumcheon-Gu Tae Kye Nam KR 153-803 153-803
FDA Registration Numbers#
- 3015729
- 3025599428
- 1032227
- 2416455
- 1054713
- 1419489
- 3003418325
- 3006621353
- 3018783058
- 3015136927
- 3002807636
- 1422375
- 3016875543
- 9681479
- 9614977
- 9614866
- 8031010
- 3000219976
- 8010468
- 3038718579
- 2020943
- 3007663058
- 2411797
- 3017618678
- 3019741877
- 3006610845
- 3030126955
- 3010864832
- 3014953747
- 3014683120
- 9611053
- 3008249935
- 3011300255
- 3005972890
- 3005164841
- 2832
- 3006531065
- 3011824442
- 2183301
- 3006444232
- 3005581016
- 3009431661
- 1722638
- 9611253
- 3012494290
- 3012477813
- 2024312
- 2127132
- 3008770655
Source Documents#
Other 510(k) Records For Product Code LQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252224 | Apex Locator (FindPex) | Changzhou Sifary Medical Technology Co., Ltd. | 2026-04-08 |
| K242383 | Apex Locator | Shenzhen Rogin Medical Co., Ltd. | 2025-03-07 |
| K242765 | Electronic Apex Locator (Alpha Apex I) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 2025-01-17 |
| K231990 | Apex Locator | Cefla S.C. | 2024-02-13 |
| K232717 | Apex Locator (AL-Pex), Apex Locator (AL-Pex+) | Changzhou Haili Medical Co., Ltd. | 2023-12-22 |
| K212178 | Root Apex Locator | Foshan Coxo Medical Instrument Co., Ltd. | 2022-07-20 |
| K210789 | EQ-PEX | Meta Systems Co., Ltd. | 2021-10-20 |
| K191806 | Propex IQ Apex Locator | Dentsply Sirona | 2019-10-03 |
| K181087 | Apex Locator, DPEX III | Guilin Woodpecker Medical Instrument Co., Ltd. | 2018-12-18 |
| K171867 | Dr’s Finder NEO | Good Doctors Co., Ltd. | 2018-03-30 |
| K151274 | Dr's Finder | Good Doctors Co., Ltd. | 2016-02-04 |
| K131907 | RAYPEX 6 | Dentsply International, Inc. | 2014-01-31 |
| K121206 | DETECT | Forum Engineering Technologies, Ltd. | 2013-01-10 |
| K112153 | IROOT 100 MINI | S-Denti Co., Ltd. | 2012-04-26 |
| K111474 | BINGO PRO | Forum Engineering Technologies (96) , Ltd. | 2011-11-02 |
Legacy Summary#
summary
FDA Review#
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