FDA.reportPublic FDA data

Planmeca Emerald S

Primary DI
00858809006170
Brand
Planmeca Emerald S
Company
D4D TECHNOLOGIES, LLC
Model
15600004 - Emerald S Scanner Kit, US
Device description
Qty 1 - 15610003 - Emerald S Scanner (US) Qty 1 - 15600104 - Emerald S Scanner Accessories (Includes 1 Scanner Cable, 1 Color Balancer, 3 Tips)
Published
2019-03-28
Public version status
Update
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
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
00858809006194PrimaryGS10
00858809006217PrimaryGS10
00858809006224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858809006170008588090061708588090061700858809006170
00858809006194008588090061948588090061940858809006194
00858809006217008588090062178588090062170858809006217
00858809006224008588090062248588090062240858809006224

GMDN Terms#

Term, Definition table
TermDefinition
Dental CAD/CAM system, chairsideAn assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (specifically prescribed to each patient's needs) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for the production of the actual devices to be fitted to the patient.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius15 Degrees Celsius
Handling Environment Temperature15 Degrees Celsius28 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius60 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00858809006224Planmeca Emerald S15600140 Emerald S Scanner Kit, Cariosity, 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
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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