FDA.reportPublic FDA data

Surgical Kit

Primary DI
08806343907172
Brand
Surgical Kit
Company
Shinhung MST Co., Ltd.
Model
STHFD01EL
Device description
These instruments are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely.
Published
2020-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJBHandle, Instrument, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806343907172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806343907172088063439071728806343907172

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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

Contacts#

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

Regulatory Flags#

DUNS number
689667152
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806343925183ever KITEVERK2025-07-28
08806343925213TAPER KITEVERKC2025-07-28
08806343925220GUIDE KITEGKC2025-07-28
08806343925237evertisMRTN2025-07-28
08806343925244evertisMRTR2025-07-28
08806343925466evertisSSD22072025-07-28
08806343925473evertisSSD22082025-07-28
08806343925480evertisSSD22102025-07-28
08806343925497evertisSSD22112025-07-28
08806343925503evertisSSD22132025-07-28
08806343925510evertisSSD22152025-07-28
08806343925527evertisNCB502025-07-28
08806343925534evertisNSSD35072025-07-28
08806343925541evertisNSSD35082025-07-28
08806343925558evertisNSSD35102025-07-28
08806343925565evertisNSSD35112025-07-28
08806343925572evertisNSSD35132025-07-28
08806343925589evertisNSSD35152025-07-28
08806343925596evertisNSSD40072025-07-28
08806343925602evertisNSSD40082025-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71050TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71060TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71070TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71080TBS BASICSACME ENTERPRISE.EJB2026-05-22
00348783010206Premier Mirror HandlesPREMIER DENTAL PRODUCTS COMPANYEJB2026-03-17
G1493807306TBS DentalACME ENTERPRISE.EJB2026-03-02
00841013120459Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
00841013120466Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
30371347019668Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019675Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019682Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019699Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017724Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017748Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00883205032164Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-21
00883205032157Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-19
08806343925183ever KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925213TAPER KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925220GUIDE KITShinhung MST Co., Ltd.EJB2025-07-28
08057639710567Specialist OrganizerMC BIO SRLEJB2025-06-23
08057639710574Tip with Indexable StopMC BIO SRLEJB2025-06-23
08057639710598Offset Tip SPMC BIO SRLEJB2025-06-23
08057639710604Long Tip SPMC BIO SRLEJB2025-06-23
08057639710628GBR MODULAR SETMC BIO SRLEJB2025-06-23
08057639712066Handle - Straight MDFMC BIO SRLEJB2025-06-23
08057639712073Handle - Straight - ErgalMC BIO SRLEJB2025-06-23
08057639712080Handle - Straight SP (TiN)MC BIO SRLEJB2025-06-23
08057639712097Handle - Asym. - ErgalMC BIO SRLEJB2025-06-23
08057639712103Handle - Asym. - SP (TiN)MC BIO SRLEJB2025-06-23
08057639712110Handle - Asym. - TitaniumMC BIO SRLEJB2025-06-23