FDA.reportPublic FDA data

Surgical Drills

Primary DI
07290116660141
Brand
Surgical Drills
Company
CORTEX - DENTAL IMPLANTS INDUSTRIES LTD
Model
CD-5003
Catalog number
CD-5003
Device description
Pilot Drill Ø=2.00mm White
Published
2026-10-11
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
07290116660141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290116660141072901166601417290116660141

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
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
07290114710039Abutments Prosthetic AccessoriesCO-0622CO-06222026-10-11
07290114710046prosthetics - Long Term abutmentsCO-0630CO-06302026-10-11
07290114710114prosthetics - Long Term abutmentsCO-5130CO-51302026-10-11
07290114710138prosthetics - Long Term abutmentsCO-5218CO-52182026-10-11
07290114710145prosthetics - Long Term abutmentsCO-5230CO-52302026-10-11
07290114710312Abutments Prosthetic AccessoriesCO-6201CO-62012026-10-11
07290114710732Indirect Transfer 13mm open trayCO-8065CO-80652026-10-11
07290116661322Surgical ToolsMCT-N215MCT-N2152026-10-11
07290114712675prosthetics - Long Term abutmentsMPR-0055MPR-00552026-10-07
07290114712682prosthetics - Long Term abutmentsMPR-0070MPR-00702026-10-07
07290114712699prosthetics - Long Term abutmentsMPR-5100MPR-51002026-10-07
07290114712705prosthetics - Long Term abutmentsMPR-5118MPR-51182026-10-07
07290114712712prosthetics - Long Term abutmentsMPR-5130MPR-51302026-10-07
07290114712729prosthetics - Long Term abutmentsMPR-5200MPR-52002026-10-07
07290114712736prosthetics - Long Term abutmentsMPR-5218MPR-52182026-10-07
07290114712743prosthetics - Long Term abutmentsMPR-5230MPR-52302026-10-07
07290114712750prosthetics - Long Term abutmentsMPR-5300MPR-53002026-10-07
07290114712149prosthetics - AnalogMPN-8040MPN-80402026-10-06
07290114712767prosthetics - Long Term abutmentsMPR-5318MPR-53182026-10-06
07290114712774prosthetics - Long Term abutmentsMPR-5330MPR-53302026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114713245prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZA2026-10-06
07290114713252prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZA2026-10-06
00887919581703DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-28
00887919581727DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581741DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581765DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
08800394921293Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921309Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921316Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921323Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921330Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921347Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921354Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921361Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921378Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921385Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921392Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921408Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921415Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921422Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921439Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921446Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921453Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921460Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921477Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08059224218007INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218014INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
06942686761223DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21