FDA.reportPublic FDA data

Surgical Kit

Primary DI
08806343901002
Brand
Surgical Kit
Company
Shinhung MST Co., Ltd.
Model
LCB50
Device description
These Drills 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
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
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806343901002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806343901002088063439010028806343901002

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82337301900syangt8823@shinhung.co.kr
+82337301913jssong@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
08806343903020Sinus KitSKRP322020-07-17
08806343903037Sinus KitSKRP372020-07-17
08806343903044Sinus KitSKRP422020-07-17
08806343903051Sinus KitSIDR202020-07-17
08806343903068Sinus KitSIDR272020-07-17
08806343903075Sinus KitSIDR322020-07-17
08806343903082Sinus KitSIDR372020-07-17
08806343903099Sinus KitSIDR422020-07-17
08806343906571Sinus KitSIDR28022020-07-17
08806343906588Sinus KitSIDR28032020-07-17
08806343906595Sinus KitSIDR28042020-07-17
08806343906601Sinus KitSITD75032020-07-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290116660677Surgical DrillsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZA2026-07-12
07290116154787Dental DrillsNORIS MEDICAL LTDDZA2026-07-09
07290116154794Diamond BurrsNORIS MEDICAL LTDDZA2026-07-09
088000702492151.2 Hex Angled Machine Screw DriverIzenimplant Co., Ltd.DZA2026-06-22
06932195393831DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393848DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393855DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393879DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393886DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393909DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393916DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393923DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393930DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393954DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393961DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393985DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195393992DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195394012DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395002DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395019DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395026DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395033DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395040DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395057DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395064DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395071DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395088DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395095DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395101DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
06932195395118DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10