FDA.reportPublic FDA data

DC-Air™ Docking Station

Primary DI
64298105870910
Brand
DC-Air™ Docking Station
Company
Athlos Oy
Model
WIOS-DS2
Device description
DC-Air™ Docking Station is intended for use as a data transfer pathway between the DC-Air™ Intraoral Sensor and a PC or laptop, and as a charging station for the DC-Air™ Intraoral Sensor.
Published
2022-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MUHSystem, X-Ray, Extraoral Source, Digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211688000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211688000DC-Air and Athlos-1 and Athlos-AirAthlos OY2021-07-22MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
64298105870910PackageGS11In Commercial Distribution
64298105870392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6429810587091064298105870910
6429810587039264298105870392

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery charger/transceiver/cableAn electrically-powered device designed to supply an electrical charge to the battery of a noninvasive device to recharge it for operation, and to both receive data from and transmit data to noninvasive devices via a direct/wired or wireless connection. It is typically in the form of an electronic circuitry housing with a cable.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
368444471
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06429810587213DC-Air™ Intraoral SensorWIOS-S2-BLACK2022-11-03
06429810587220DC-Air™ Intraoral SensorWIOS-S2-BLACK2022-11-03
06429810587008DC-Air™ Intraoral SensorWIOS-S22022-03-10
06429810587039DC-Air™ Docking StationWIOS-DS22022-03-10
06429810587145DC-Air™ Holder PackDC-HP-12022-03-10
64298105870606DC-Air™ Intraoral SensorWIOS-S22022-03-10
64298105871450DC-Air™ Holder PackDC-HP-12022-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011175704A2Z ImagingZINNOVI INC.MUH2026-06-05
00860011175711A2Z ImagingZINNOVI INC.MUH2026-06-05
00860009306110Cleartooth Digital X-RayCLEARTOOTH ELECTRONICS, INC.MUH2026-05-27
08800011200060Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011200084Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
D090101397120IXS S2 Kit, CT, US, FR-CADental Imaging Technologies CorporationMUH2026-05-12
D090101329460DEXIS IXS Size 1 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090101329470DEXIS IXS Size 2 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090800045720DEXIS Ti2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045730DEXIS IXS Size 1 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045740DEXIS IXS Size 1 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045750DEXIS IXS Size 2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045760DEXIS IXS Size 2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045770DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045780DEXIS IXS Size 2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800045790DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045810DEXIS IXS S2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045830DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045840DEXIS Ti2 Kit - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045850IXS S1 Warranty Replacement - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045860IXS S1 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045870IXS S2 Warranty NEW KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045880IXS S2 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049760DEXIS Ti2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049770DEXIS IXS Size 1 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049790DEXIS Ti2 Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049800DEXIS Ti2 Sensor & Acc. Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049810DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049820DEXIS IXS Size 2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800457100DEXIS Ti2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01