FDA.reportPublic FDA data

Surgical Drills

Primary DI
07290116660677
Brand
Surgical Drills
Company
CORTEX - DENTAL IMPLANTS INDUSTRIES LTD
Model
CK-GS11
Catalog number
CK-GS11
Device description
COR Kit Guided Surgery
Published
2026-07-12
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
false

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
07290116660677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290116660677072901166606777290116660677

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
532376956
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
07290112780010Magix (Prime)BCDL-0833BCDL-08332026-07-12
07290112780522Dynamix Hex (Prime)BCSD-1050BCSD-10502026-07-12
07290112780645Dynamix Hex (Prime)BCSD-1633BCSD-16332026-07-12
07290112780652Dynamix Hex (Prime)BCSD-1638BCSD-16382026-07-12
07290112781215Saturn (Prime)BST-1038BST-10382026-07-12
07290112781222Saturn (Prime)BST-1042BST-10422026-07-12
07290112781246Saturn (Prime)BST-1142BST-11422026-07-12
07290112781260Saturn (Prime)BST-1342BST-13422026-07-12
07290112781284Saturn (Prime)BST-1642BST-16422026-07-12
07290112781710Dynamix Hex (Premium)PCSD-1038PCSD-10382026-07-12
07290112781727Dynamix Hex (Premium)PCSD-1042PCSD-10422026-07-12
07290114710411Healing CapCO-7103CO-71032026-07-12
07290114710565AbutmentsCO-8015CO-80152026-07-12
07290114712156Abutments-AnalogMPN-8040DMPN-8040D2026-07-12
07290114712613Titanium-basesMPN-TBH1MPN-TBH12026-07-12
07290116660882Surgical ToolsCT-0254CT-02542026-07-12
07290116660899Surgical ToolsCT-0260CT-02602026-07-12
07290116660981Surgical ToolsCT-0801CT-08012026-07-12
07290116661216Surgical ToolsCT-S215CT-S2152026-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
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