FDA.reportPublic FDA data

Markley Threaded Wire .018

Primary DI
D876380180
Brand
Markley Threaded Wire .018
Company
ALMORE INTERNATIONAL INC
Model
38018
Catalog number
38018
Device description
One foot of stainless steel threaded wire that can be cut to length for pins and posts. The smaller diameter are used for dentin pins giving better retention to amalgam fillings on vital teeth. A variety of diameters are used for endo posts to strengthen and build up endodontically treated teeth. The threaded nature of the wire provides for better retention.
Published
2019-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EBLPin, Retentive And Splinting, And Accessory Instruments

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBLPin, Retentive And Splinting, And Accessory InstrumentsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D876380180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration retention pinA device intended to be placed permanently in the tooth to provide retention and/or stabilization for a dental restoration (e.g., a filling or a crown). It is typically made of stainless steel or titanium (Ti) and comes in a variety of sizes (e.g., 1.0 mm to 3.2 mm). The device is inserted into a pre-drilled hole in the tooth and is secured by threading, friction and/or cementing.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
009051723
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D876936060Etch Gel (12 grams) with 25 tips 93606936062019-11-15
D876938521Uni-Wedge, Regular938522019-07-24
D876380640Markley Threaded Wire .06438064380642019-07-26
D876222170Ultimate Flosser (White Fork/White Body)22217222172019-07-26

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