FDA.report

CS 3500 3D Scanner Small Tip

Primary DI
60889976567883
Brand
CS 3500 3D Scanner Small Tip
Company
CARESTREAM HEALTH, INC.
Model
CS 3500 3D Scanner Small Tip
Catalog number
6567887
Device description
CS3500 SMALL TIP (5 PIECES)
Published
2016-09-16
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

Related Records

Product Codes

CodeName
NOFSystem, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations

Product Code Classifications

CodeDeviceSpecialtyClass
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
60889976567883PrimaryGS10
00889976567881Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
6088997656788360889976567883
00889976567881008899765678818899765678810889976567881

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius24 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
793169512
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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