Planmeca Emerald

GUDID 00858809006156

Qty 1 - 15610001 - Emerald Scanner (US) Qty 1 - 15600101 - Emerald Scanner Accessories (Includes 1 Scanner Cable, 1 Color Balancer, 3 Tips)

D4D TECHNOLOGIES, LLC

Dental CAD/CAM system, chairside

Primary Device ID	00858809006156
NIH Device Record Key	f3e8528b-d37c-48bd-b505-290a3f8e9cd6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Planmeca Emerald
Version Model Number	156100001 Emerald Scanner Kit - US
Company DUNS	138121202
Company Name	D4D TECHNOLOGIES, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858809006132 [Direct Marking]
GS1	00858809006156 [Primary]

FDA Product Code

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