FDA.reportPublic FDA data

CICADA

Primary DI
06974456210105
Brand
CICADA
Company
Foshan Cicada Dental Instrument Co., Ltd.
Model
CV/DX
Device description
Low-Speed Air Turbine Handpieces
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
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181900000Dental high speed handpiece, Dental low speed handpieceFoshan Cicada Dental Instrument Co, Ltd.2019-12-09EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974456210105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974456210105069744562101056974456210105

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motor, pneumaticA hand-held, pneumatically-powered component of a surgical power tool assembly designed to convert the energy from a compressed gas source [e.g., surgical-grade air or nitrogen (N2)] 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
Donation ID number
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
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
06974456210662CICADANL400-12024-08-09
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
00810021439778DCI EdgeDCI International, LLCEFB2026-06-01
00810021439785DCI EdgeDCI International, LLCEFB2026-06-01
07640397422028Statcare sprayDent4You AGEFB2026-04-24
07640397422035Statmatic sprayDent4You AGEFB2026-04-24
J021020835001MCA-RM-BCW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J0071600436001USA1PM 1:2Bien-Air Dental SAEFB2025-10-13
J0071600052001USA1PM 1:1 EXT SPRAYBien-Air Dental SAEFB2025-10-10
J0071600692001USA1CA 20:1 L MICRO-SERIESBien-Air Dental SAEFB2025-10-10
J0071601136001USA1CA NOVA 1:1L MSBien-Air Dental SAEFB2025-10-10
J0071601138001USA1CA NOVA 1:5L MSBien-Air Dental SAEFB2025-10-10
J021300850001WG-67 AW & H Dentalwerk Bürmoos GmbHEFB2025-03-04
J021300740001TE-95 BC TurbineW & H Dentalwerk Bürmoos GmbHEFB2024-07-29
J021112330111OS30W & H Dentalwerk Bürmoos GmbHEFB2024-07-03
J00715031850011NGO motor driverBien-Air Dental SAEFB2023-09-15
J021026904001MCA-RM-RQW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021026930001MCA-ISO-CKW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021031035001MCA-ISO-MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021052046001MCA-ISO-PLW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021060371001Universal Adapter VDWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021111443001RC-43 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021112458001RC-58 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301040001AM-25 A BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301090001AM-20 E BCW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301110001AM-25 E BC AirmotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301120001AM-25 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301130001AM-20 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301240011WE-56 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301250011WE-57 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301260011HE-43 T MW Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301270011WE-56 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11