FDA.reportPublic FDA data

SE

Primary DI
08806343906304
Brand
SE
Company
Shinhung MST Co., Ltd.
Model
EBCN5044H
Device description
This product is used to implement fixture, abutment of oral cavity in impression acquisition and work model during dental implant procedure.
Published
2020-07-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGGAttachment, Precision, All

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806343906304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806343906304088063439063048806343906304

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure kitA collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82337301900syangt8823@shinhung.co.kr

Regulatory Flags#

DUNS number
689667152
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806343912961MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF2202026-04-13
08806343912978MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF3202026-04-13
08806343912985MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF4202026-04-13
08806343912992MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF5202026-04-13
08806343913005MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF6202026-04-13
08806343913012MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF1252026-04-13
08806343913029MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF2252026-04-13
08806343913036MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF3252026-04-13
08806343913043MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF4252026-04-13
08806343913050MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF5252026-04-13
08806343913067MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF6252026-04-13
08806343913074MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF1302026-04-13
08806343913081MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF2302026-04-13
08806343913098MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF3302026-04-13
08806343913104MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF4302026-04-13
08806343913111MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF5302026-04-13
08806343913128MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF6302026-04-13
08806343913135MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF1352026-04-13
08806343913142MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF2352026-04-13
08806343913159MAGDEN DENTAL IMPLANT SYSTEMS.MAGFIT IP-GF3352026-04-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840481136023LOCATOR, compatible with Implant DirectZest Anchors, LLCEGG2026-02-18
00840481136917LOCATOR R-Tx, Dentsply Sirona System Zest Anchors, LLCEGG2026-02-18
00840481136924LOCATOR R-Tx, Dentsply Sirona System Zest Anchors, LLCEGG2026-02-18
07640239932562Dalbo®-ClassicCendres+Métaux SAEGG2026-02-16
07640239932579Dalbo®-ClassicCendres+Métaux SAEGG2026-02-16
08059224127798OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224129044PLUSRHEIN 83 SRLEGG2026-02-10
08059224129099PLUSRHEIN 83 SRLEGG2026-02-10
08059224129143PLUSRHEIN 83 SRLEGG2026-02-10
08059224133041OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224133058OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224134260OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224167503PLUSRHEIN 83 SRLEGG2026-02-10
08059224167510PLUSRHEIN 83 SRLEGG2026-02-10
08059224167534PLUSRHEIN 83 SRLEGG2026-02-10
08059224167541PLUSRHEIN 83 SRLEGG2026-02-10
08059224167558PLUSRHEIN 83 SRLEGG2026-02-10
08059224167565PLUSRHEIN 83 SRLEGG2026-02-10
08059224167572PLUSRHEIN 83 SRLEGG2026-02-10
08059224167589PLUSRHEIN 83 SRLEGG2026-02-10
08059224167596PLUSRHEIN 83 SRLEGG2026-02-10
08059224167602PLUSRHEIN 83 SRLEGG2026-02-10
08059224167619PLUSRHEIN 83 SRLEGG2026-02-10
08059224167626PLUSRHEIN 83 SRLEGG2026-02-10
08059224167633PLUSRHEIN 83 SRLEGG2026-02-10
08059224167640OT EQUATORRHEIN 83 SRLEGG2026-02-10
08059224185040OT CAPRHEIN 83 SRLEGG2026-02-10
08059224209234OT CAPRHEIN 83 SRLEGG2026-02-10
08059224209241OT CAPRHEIN 83 SRLEGG2026-02-10
08059224209272OT CAPRHEIN 83 SRLEGG2026-02-10