FDA.reportPublic FDA data

Planmeca Emerald S

Primary DI
00858809006224
Brand
Planmeca Emerald S
Company
D4D TECHNOLOGIES, LLC
Model
15600140 Emerald S Scanner Kit, Cariosity, US
Device description
Qty 1 - 15610003 - Emerald S Scanner (US)Qty 1 - 15600141 - Emerald S Scanner AccessoriesQty 1 - 15693001 Cariosity Tip
Published
2022-07-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
NTKCaries Detector, Laser Light, Transmission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsDental2
NTKCaries Detector, Laser Light, TransmissionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858809006170Direct MarkingGS10
00858809006224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858809006170008588090061708588090061700858809006170
00858809006224008588090062248588090062240858809006224

GMDN Terms#

Term, Definition table
TermDefinition
Dental caries detector, optical induced fluorescenceA mains electricity (AC-powered) device designed to determine the changes in the fluorescence of teeth enamel and dentine due to mineral loss, mainly for the diagnosis of early stage dental caries and/or to monitor the progress of caries. It consists of a light source (typically a laser) that elicits fluorescence in teeth, and a unit that quantifies the altered fluorescence of the carious tooth tissue.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius15 Degrees Celsius
Storage Environment Temperature28 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
138121202
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858809006163Planmeca Emerald15600002 Emerald Scanner Kit - OY2019-03-01
00858809006194Planmeca Emerald S15600004 - Emerald S Scanner Kit, US2019-03-28
00858809006200Planmeca Emerald S15600005 - Emerald S Scanner Kit, OY2019-03-28
00858809006217Planmeca Emerald S15600012 Promo ORTHO Emerald S Scanner Kit, US2022-07-06
00858809006019PlanScan12370004 PlanScan Scanner C-US2016-09-19
00858809006026PlanScan12395801 Scanner Tip Landscape Autoclave2016-09-19
00858809006071PlanScan10826802 Scanner Tip Variety Autoclave (US)2016-09-19
00858809006156Planmeca Emerald156100001 Emerald Scanner Kit - US2019-03-01
00858809006002PlanScan12370003 PlanScan Scanner (US)2016-09-19
00858809006033PlanScan12395901 Scanner Tip Portrait Autoclave2016-09-19
00858809006040PlanScan12398101 Scanner Color Tip2016-09-19
00858809006057PlanScan12395701 Scanner Tip Standard Autoclave2016-09-19
00858809006064PlanScan125395601 Scanner Tip Standard Autoclave2016-09-19
00858809006118PlanScan12398103 - Scanner Tip Color Variety Pack2016-12-21
00858809006170Planmeca Emerald S15600004 - Emerald S Scanner Kit, US2019-03-28
00858809006187Planmeca Emerald S15600005 - Emerald S Scanner Kit, OY2019-03-28
00858809006149Planmeca Emerald15600002 Emerald Scanner Kit - OY2019-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970163089140SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-20
06975456126007UP3D Intraoral ScannerShenzhen UP3d Technology Co., Ltd.NOF2026-05-18
06970163084022SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
06970163084039SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
06970163084046SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
08800026700760Medit Link ExpressMedit Corp.NOF2026-04-28
08800026700883Medit Link ExpressMedit Corp.NOF2026-04-28
06973993442499Intraoral ScannerAlliedstar Medical Equipment Co., Ltd.NOF2026-04-20
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCNOF2026-04-13
06970163089966SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089973SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089836SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-16
D745701181MIL001610150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
D745701181MIL046710150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
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07540209957642MicronMapperClaronav IncNOF2026-02-10