FDA.report

Profibase

Primary DI
E22121141
Brand
Profibase
Company
VOCO GmbH
Model
2114
Catalog number
2114
Device description
Profibase is a light-curing resin in pre-contoured plates for maxillae and mandibles for the fabrication of individual impression and functional trays for use in crown, bridge and total prosthetic technique to be used for the fabrication of bases of bite patterns as well as for dimensionally stable base plates for wax contouring in the total prosthetic technique. The material is ready for use and easy to handle.
Published
2019-06-06
Public version status
New
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

Contact Domains

Product Codes

CodeName
EBHMaterial, Impression Tray, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E22121141PrimaryHIBCC0
E2212114Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental base plateA foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags

DUNS number
316699578
Device count
2
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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