Data / Medical devices / China / Shenzhen Ainengke Electronics Co, Ltd
Shenzhen Ainengke Electronics Co, Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 4 510(k) clearances
Shenzhen Ainengke Electronics Co, Ltd is registered with the FDA (registration 3033858988) in Shenzhen Guangdong, China. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 4, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033858988
- Address
- Building B, 5th Floor, Jinshenghui Technology Park, No. 3, Dafu Industrial Zone, Dafu Community Guanlan Subdistrict, Longhua District, Shenzhen Guangdong, China, 518110
- Owner or operator
- SHENZHEN AINENGKE ELECTRONICS CO, LTD (10091785)
- Roles
- Manufacturer
- First device listed
- November 1, 2024
- Registered through
- 2026
- Brand names listed
- Curwy Moon Electric Teeth Cleaner, Dental mirro, Flat head, pointed end; toothbrush,powerd: T4,T5,T6,T7,T8,T9,T10,M1,M2,M3,M4,M5,T11,T12,T13,T14,T15,X7,X8,X9,W7,W8,W9, Household Tooth Polisher: X1Pro, X2Pro, X3Pro, X4Pro, X5Pro, X6Pro, X7Pro, X8Pro, X9Pro, X10Pro, X11Pro, X12Pro, Jacquette Scaler, PLUSTRON ION TOOTHBRUSH SYSTEM, A-10 Plaque Remover for Teeth, Tartar Remover Kit, Dental Cleaning Tools, RELACS 7000, Plaque remover for teeth, Tartar Remover for Teeth, Teeth Cleaning Kit, 5 Modes with 3 tips, with LED Light, SPARTAN A-10 Plaque Remover for Teeth, Tartar Remover Kit, Dental Cleaning Tools and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mirror, Mouth | EAX | 1 | Manufacturer | accessdata.fda.gov |
| Powered Tongue Scraper | QIA | 1 | Manufacturer | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Manufacturer | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Manufacturer | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Ionic, Battery-Powered | MMD | 1 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 4, 2000 | K002753 | SPARTAN A-10 | ELC | Substantially Equivalent | Spartan Ultrasonics, Inc. | accessdata.fda.gov |
| June 24, 1997 | K971639 | PLUSTRON ION TOOTHBRUSH SYSTEM | MMD | Substantially Equivalent | Sas Group, Inc. | accessdata.fda.gov |
| May 12, 1995 | K951272 | RELACS 7000 | ELC | Substantially Equivalent | Micro-Mega Societe Anonyme | accessdata.fda.gov |
| April 16, 1991 | K903298 | DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP | ELC | Substantially Equivalent | Micro Motors, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mirror, Mouth
- All makers of Unit, Oral Irrigation
- All makers of Powered Tongue Scraper
- All makers of Scaler, Ultrasonic
- All makers of Toothbrush, Ionic, Battery-Powered
- All makers of Scaler, Periodontic
Updated December 4, 2000. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.