FDA.reportPublic FDA data

Rebilda Post GT

Primary DI
E22119721
Brand
Rebilda Post GT
Company
VOCO GmbH
Model
1972
Device description
set, 5 posts each (~ ø 0,8 mm, ~ ø 1,0 mm, ~ ø 1,2 mm, ~ ø 1,4 mm), Ceramic Bond, Bottle, 5 ml, Futurabond U Single Dose (20 pcs.), Rebilda DC QuickMix syringe 10 g dentine
Published
2017-11-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
EHQCusp, Preformed
ELRPost, Root Canal
EMACement, Dental
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EHQCusp, PreformedDental1
ELRPost, Root CanalDental1
EMACement, DentalDental2
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E22119721PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Root canal post, preformedA prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius23 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags#

DUNS number
316699578
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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