510(k) K240707
- Device
- Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)
- Applicant
- Shenzhen Micro Electric Intelligence Co., Ltd.
- 510(k) number
- K240707
- Product code
- ELC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-02
- Date received
- 2024-03-15
- Regulation
- 872.4850
- Classification name
- Scaler, Ultrasonic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Fengmeng Han
- Address
- 301, Bldg. A5, # 13 Baonan Rd., Longgang Community Longgang District Shenzhen CN 518100 518100
FDA Registration Numbers
- 3008912871
- 3003934980
- 1032227
- 1054713
- 3008770655
- 3004569445
- 3013022399
- 3004884150
- 3003933619
- 3008615394
- 9710363
- 3008910197
- 3012187973
- 8044015
- 9681479
- 1718912
- 9614726
- 1941138
- 3030405669
- 3000219976
- 2127132
- 3010373292
- 9616762
- 3022516928
- 9614977
- 3004193466
- 3013298431
- 2031508
- 3010864832
- 1419489
- 2024980
- 3009968482
- 3015729
- 3012477813
- 3010817521
- 2521453
- 3012421607
- 3016075921
- 2511556
- 2020943
- 3005282635
- 2320721
- 2424472
- 3012322979
- 1722638
- 3003637274
- 3006750855
- 8032033
- 9611253
- 3008590661
- 3005972890
- 3012494290
- 3010364969
- 2024312
- 3027615
- 3012354669
- 2832
- 8044167
- 2416455
- 2411797
- 1422375
- 8043962
- 3018783058
- 3014683120
- 2183301
- 3038718579
- 3008559238
- 3017618678
- 3011944170
- 3006610845
- 3007962015
- 3004096429
- 3014315145
- 3005581016
- 3030126955
- 1413475
- 1416605
- 3016114530
- 2520265
- 3018975080
Source Documents
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