FDA.reportPublic FDA data

Disposable Sleeve Omnicam (50 pcs.)

Primary DI
E27666322640
Brand
Disposable Sleeve Omnicam (50 pcs.)
Company
SIRONA Dental Systems GmbH
Model
6632264
Published
2022-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E27666322640PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental CAD/CAM system, chairsideAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+496251161670contact@dentsplysirona.com

Regulatory Flags#

DUNS number
340306351
Device count
1
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E27668665320Midwest IMPLANT 20:168665322026-02-19
E27668312130Midwest Motor Control Module683121368312132026-02-17
E27668234260Primevision 3D675859867585982026-02-13
E27668302980Midwest Power Lux Implant Motor683029868302982026-02-13
E27668303060Midwest Power Lux Motor683030668303062026-02-13
E27665716860SiroLaser65716862025-09-03
E27662122080Motor BL implant62122082025-08-20
E27668534800CAD/CAM Software68534802025-08-19
E2766802040Primescan 2680204068020402025-05-16
E27668020400Primescan 2680204068020402025-05-16
E27668053650Primescan 2 Multiuse Sleeve680536568053652025-05-06
E27668325750TiBase683257568325752025-05-06
E27668325830TiBase683258368325832025-05-06
E27668326090TiBase683260968326092025-05-06
E27668326170TiBase683261768326172025-05-06
E27668326250TiBase683262568326252025-05-06
E27668326330TiBase683263368326332025-05-06
E27668326580TiBase683265868326582025-05-06
E27668326660TiBase683266668326662025-05-06
E27668004570Primescan 2 Cart680045768004572025-03-05

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Primary DI, Brand, Company table
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D745701181MIL001610150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
D745701181MIL046710150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
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