Planmeca Emerald S

GUDID 00858809006187

Qty 1 - 1560004 - Emerald S Scanner (US) Qty 1 - 15600105 - Emerald S Scanner Accessories (Includes 1 Scanner Cable, 1 Color Balancer, 3 Tips)

D4D TECHNOLOGIES, LLC

Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside
Primary Device ID00858809006187
NIH Device Record Key13fc2027-ae1e-4b14-a7c7-7449af62c108
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlanmeca Emerald S
Version Model Number15600005 - Emerald S Scanner Kit, OY
Company DUNS138121202
Company NameD4D TECHNOLOGIES, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100858809006187 [Direct Marking]
GS100858809006200 [Primary]

FDA Product Code

NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


[00858809006187]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-28
Device Publish Date2019-03-28

On-Brand Devices [Planmeca Emerald S]

00858809006187Qty 1 - 1560004 - Emerald S Scanner (US) Qty 1 - 15600105 - Emerald S Scanner Accessories (Inclu
00858809006170Qty 1 - 15610003 - Emerald S Scanner (US) Qty 1 - 15600104 - Emerald S Scanner Accessories (Incl

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