Planmeca Emerald

GUDID 00858809006149

Qty 1 - 15610002 - Emerald Scanner (OY) Qty 1 - 15600102 - Emerald Scanner Accessories (Includes 1 Scanner Cable, 1 Color Blancer, 3 Tips)

D4D TECHNOLOGIES, LLC

Dental CAD/CAM system, chairside
Primary Device ID00858809006149
NIH Device Record Key0a9103ff-07a9-460b-952a-b81ac67e5ce0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlanmeca Emerald
Version Model Number15600002 Emerald 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
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
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
GS100858809006149 [Direct Marking]
GS100858809006163 [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

[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

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[00858809006149]

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[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


[00858809006149]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-28
Device Publish Date2019-03-01

On-Brand Devices [Planmeca Emerald]

00858809006149Qty 1 - 15610002 - Emerald Scanner (OY) Qty 1 - 15600102 - Emerald Scanner Accessories (Includes
00858809006156Qty 1 - 15610001 - Emerald Scanner (US) Qty 1 - 15600101 - Emerald Scanner Accessories (Includes

Trademark Results [Planmeca Emerald]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PLANMECA EMERALD
PLANMECA EMERALD
87460742 5899998 Live/Registered
Planmeca Oy
2017-05-23

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