510(k) K242646
- Device
- Dental Implant Unit
- Applicant
- Guilin Aesthedent Medical Instruments Co., Ltd.
- 510(k) number
- K242646
- Product code
- EBW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-11
- Date received
- 2024-09-03
- Regulation
- 872.4200
- Classification name
- Controller, Foot, Handpiece And Cord
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Chen Salon
- Address
- 3rd Floor, Bldg. 12th, Guilin Creative Industry Park # 70, Qilidian Rd., Qixing District Guilin CN 541004 541004
FDA Registration Numbers#
- 3013576763
- 3003637274
- 3015729
- 3025599428
- 1032227
- 1054713
- 1419489
- 9614446
- 3004884150
- 3027339877
- 3015231789
- 1422375
- 3015272949
- 9681479
- 9614977
- 3017403245
- 8010493
- 3025764223
- 3009161350
- 3009768364
- 3011649314
- 8020776
- 3021336182
- 3038718579
- 8044015
- 2320721
- 3030091468
- 9710363
- 3006540014
- 3006610845
- 3030126955
- 3019269298
- 3014953747
- 3004082152
- 3014683120
- 3007345485
- 3010400367
- 3011300255
- 3005972890
- 3003934980
- 3036269993
- 3014004349
- 3011824442
- 3010185635
- 3016727307
- 3007007357
- 3005581016
- 3010331645
- 2520265
- 3017604
- 9611253
- 3010551934
- 9681851
- 3012477813
- 3010162973
- 3009302876
- 3021226419
- 2024312
- 3007126709
- 3030926959
- 3013767421
- 3007518363
- 3007958831
- 3007279848
- 3029780
- 3031093388
- 3003268570
- 3003548115
- 3010097171
Source Documents#
Other 510(k) Records For Product Code EBW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251407 | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | 2026-01-30 |
| K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | 2026-01-12 |
| K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | 2025-08-25 |
| K231562 | ELEC ENGINE (Model: ISE-170L) | Micro-Nx Co., Ltd. | 2025-07-18 |
| K233288 | NLZ Built-In Motor System | Nakanishi, Inc. | 2024-06-24 |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Nakanishi, Inc. | 2024-06-20 |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, | Cefla S.C. | 2024-04-01 |
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. | 2024-03-11 |
| K211358 | Implanter incl. Accessories | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-11-21 |
| K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan Coxo Medical Instrument Co., Ltd. | 2022-09-27 |
| K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED | Cefla S.C. | 2022-05-09 |
| K202075 | Dental Electric Motor | Foshan Cicada Dental Instrument Co, Ltd. | 2022-03-11 |
| K201191 | ELEC-LED | Micro-Nx Co., Ltd. | 2022-02-07 |
| K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-01-13 |
| K201192 | Impla-NX (Model: ISE-270M) | Micro-Nx Co., Ltd. | 2021-05-21 |