AccessGUDID - DEVICE: Planmeca Emerald S (00858809006224)

GUDID

Device Identifier (DI) Information

Brand Name: Planmeca Emerald S
Version or Model: 15600140 Emerald S Scanner Kit, Cariosity, US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: D4D TECHNOLOGIES, LLC

Primary DI Number: 00858809006224
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 138121202 *Terms of Use

Device Description: Qty 1 - 15610003 - Emerald S Scanner (US) Qty 1 - 15600141 - Emerald S Scanner Accessories Qty 1 - 15693001 Cariosity Tip

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33995	Dental caries detector, optical induced fluorescence	A 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.	Active	false
38597	Dental milling system, CAD/CAM, chairside	An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NTK	Caries Detector, Laser Light, Transmission
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1aec8740-4f55-4bef-95f8-1eceb7a3835e
Public Version Date: July 16, 2024
Public Version Number: 3
DI Record Publish Date: July 06, 2022