FDA.reportPublic FDA data

CICADA

Primary DI
06974456210662
Brand
CICADA
Company
Foshan Cicada Dental Instrument Co., Ltd.
Model
NL400-1
Device description
Dental Electrical Motors
Published
2024-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBWController, Foot, Handpiece And Cord

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202075000Dental Electric MotorFoshan Cicada Dental Instrument Co, Ltd.2022-03-11EBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974456210662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974456210662069744562106626974456210662

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motor, electricA hand-held, electrically-powered component of a dental power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
529797591
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974456210815CICADAEASY REMOVER 012024-08-10
06974456210259CICADAT-Fine-II2024-08-09
06974456210051CICADAS-30G-262024-08-10
06974456210211CICADAO-30G-262024-08-10
06974456210228CICADAS-26G-262024-08-10
06974456210761CICADAK2024-08-10
06974456210778CICADACV-EN2024-08-10
06974456210020CICADACV/GX2024-08-09
86974456210057CICADAS-30G-262024-08-10
06974456210105CICADACV/DX2024-08-09
06974456210112CICADACV-288-2.52024-08-10
86974456210217CICADAO-30G-262024-08-10
86974456210224CICADAS-26G-262024-08-10
06974456210518CICADADT-JCQ-I2024-08-10
06974456210617CICADACV-Fill-P12024-08-10
86974456210767CICADAK2024-08-10
86974456210774CICADACV-EN2024-08-10
06974456210983CICADACV-2182024-08-09
06974456210037CICADACV-215-G22024-08-07
06974456210044CICADACV-215-G12024-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589551395088Multi Pad2NAKANISHI INC.EBW2026-06-02
08033837935889AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935896AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935902Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935919Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935926CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935933CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08809260475519X-CUBESaeshin Precision Co., Ltd.EBW2026-04-02
08809260475403AHP-85-SSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475410TRAUSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475359SDI10Saeshin Precision Co., Ltd.EBW2026-03-04
10194665008444A-decA-DEC, INC.EBW2026-02-19
10194665008475A-decA-DEC, INC.EBW2026-02-19
10194665008482A-decA-DEC, INC.EBW2026-02-19
10194665008499A-decA-DEC, INC.EBW2026-02-19
10194665008505A-decA-DEC, INC.EBW2026-02-19
10194665008512A-decA-DEC, INC.EBW2026-02-19
10194665008529A-decA-DEC, INC.EBW2026-02-19
10194665008550A-decA-DEC, INC.EBW2026-02-19
E27668312130Midwest Motor Control ModuleSIRONA Dental Systems GmbHEBW2026-02-17
E27668302980Midwest Power Lux Implant MotorSIRONA Dental Systems GmbHEBW2026-02-13
E27668303060Midwest Power Lux MotorSIRONA Dental Systems GmbHEBW2026-02-13
00810126043153SM7 US ( Complete Set )HIOSSEN, INC.EBW2026-01-09
00810126043160S200EML (Contra) Dental Surgery Hand PieceHIOSSEN, INC.EBW2026-01-09
08404535021684ForzaPeter Brasseler Holdings, LLCEBW2026-01-09
08404535021714ForzaPeter Brasseler Holdings, LLCEBW2026-01-09
04589551393381Straumann SGL80MNAKANISHI INC.EBW2026-01-03
04589551393374Straumann Surgical Motor Pro 2NAKANISHI INC.EBW2026-01-03
04589551384082Straumann SGL80MNAKANISHI INC.EBW2026-01-03
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2025-12-18