FDA.reportPublic FDA data

evertis

Primary DI
08806343920447
Brand
evertis
Company
Shinhung MST Co., Ltd.
Model
ZTBC35044H
Device description
Used when taking impressions to make Zimmer TSV prostheses.
Published
2021-08-19
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
08806343920447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806343920447088063439204478806343920447

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82337301913jssong@shinhung.co.kr
+82337301917syangt8823@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
H0005KX40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2026-05-08
H0005TX40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2026-05-08
ESTOI0107K5000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-10-14
ESTOV0003X2600StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-10-08
ESTOI6501K3000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-05-22
ESTOI6501K4500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2025-05-22
00840481134104LOCATOR, compatible with Implant DirectZest Anchors, LLCEGG2023-11-10
18056039211336NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211503NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211510NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
18056039211527NOBIL METAL SPANOBIL METAL SPAEGG2023-10-05
07640166516125Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093121Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093145Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
07640173093268Mini-SG® / Mini-SG® F/R / M-SG® Star 1Cendres+Métaux SAEGG2023-09-05
ESTOH0004K20StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004K30StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004K40StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004X20StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOH0004Z10StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOU0001Z315K0StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOV0001X2500StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
ESTOV0001Z3000StecoTitanmagnetics®steco-System-Technik GmbH & Co KGEGG2023-07-24
00810053771891PrimeLocIPBEGG2022-12-15
07630031758743NAInstitut Straumann AGEGG2022-12-02
07630031758750NAInstitut Straumann AGEGG2022-12-02
07630031758767NAInstitut Straumann AGEGG2022-12-02
07630031758774NAInstitut Straumann AGEGG2022-12-02
07630031758781NAInstitut Straumann AGEGG2022-12-02
07630031758798NAInstitut Straumann AGEGG2022-12-02