FDA.reportPublic FDA data

Eighteeth

Primary DI
06975132957345
Brand
Eighteeth
Company
Changzhou Sifary Medical Technology Co., Ltd.
Model
Fast-Pack pro
Published
2024-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKRPlugger, Root Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975132957345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975132957345069751329573456975132957345

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation systemAn assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
560366787
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941877830090EighteethE-FLEX REC-20351831062026-06-09
06941877830106EighteethE-FLEX REC-22051831232026-06-09
06941877830113EighteethE-FLEX REC-22151831242026-06-09
06941877830076EighteethE-FLEX REC-20151831042026-05-26
06941877830083EighteethE-FLEX REC-20251831052026-05-26
06941877829704EighteethFindPex61801532026-05-07
06941877829728EighteethOrion Kit-M1.476801632026-05-07
06941877829735EighteethOrion Kit-M1.676801642026-05-07
06941877829742EighteethOrion Kit-M1.876801652026-05-07
06941877829759EighteethOrion SC-M1.476801662026-05-07
06941877829766EighteethOrion SC-M1.676801672026-05-07
06941877829773EighteethOrion SC-M1.876801682026-05-07
06941877829780EighteethOrion SS-M1.476801692026-05-07
06941877829797EighteethOrion SM-M1.476801702026-05-07
06941877829803EighteethOrion SL-M1.476801712026-05-07
06941877829810EighteethOrion SS-M1.676801722026-05-07
06941877829827EighteethOrion SM-M1.676801732026-05-07
06941877829834EighteethOrion SL-M1.676801742026-05-07
06941877829841EighteethOrion SS-M1.876801752026-05-07
06941877829858EighteethOrion SM-M1.876801762026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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