FDA.report

x-tra base

Primary DI
E22117951
Brand
x-tra base
Company
VOCO GmbH
Model
1795
Catalog number
1795
Device description
Flowable light-curing base composite. 4 mm restorarion base in one simple step. Perfect furface affinity for outstanding adaption. Low shrinkage stress. High radiocapacity (350 %Al). Self-levelling. Can be combined with any methacrylates-based bonding or composite. The non-dripping NDT-syringe or convenient Flow-Caps with bendable metal cannualae ensure a reliable, precisely accurate application.
Published
2016-08-31
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

Contact Domains

Product Codes

CodeName
EJKLiner, Cavity, Calcium Hydroxide

Product Code Classifications

CodeDeviceSpecialtyClass
EJKLiner, Cavity, Calcium HydroxideDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E22117951PrimaryHIBCC0
E22117950Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius23 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags

DUNS number
316699578
Device count
16
DM exempt
false
Premarket exempt
false
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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