FDA.report

Optimet

Primary DI
07290016827019
Brand
Optimet
Company
OPTIMET
Model
DSI - Impression Scanner
Device description
Optical Desktop Scanner with accessories for scanning models and impression.
Published
2016-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

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
07290016827019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290016827019072900168270197290016827019

GMDN Terms

TermDefinition
Dental CAD/CAM system, laboratoryAn assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations and/or orthodontic appliances (archwires) produced in the dental laboratory. It typically includes three-dimensional (3-D) image acquisition capabilities that provide values (measurements) from, e.g., casts, models or chairside in vivo acquisition to acquire the prescription values for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for production of the actual device(s) for delivery for final fitting to the patient.

Sterilization Methods

Method

Contacts

PhoneEmail
978-657-6303marketing@optimet.com

Regulatory Flags

DUNS number
531984441
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07290016827002OptimetDSI - Impression Scanner2016-11-21
07290016827026Nobel Procera1.32016-11-21
07290016827033Nobel Procera 2G2016-11-21

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