FDA.reportPublic FDA data

CET Gate Drills

Primary DI
00850085821126
Brand
CET Gate Drills
Company
CREATIVE ENDODONTIC TECHNOLOGY LLC
Model
GD-3-28MM-6PK
Device description
Gate Drills, #3, 28mm, Pack of 6
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00850085821126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850085821126008500858211268500858211260850085821126

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, single-useA 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 motorized handpiece or other power source that provides rotation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
144413963
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850085821171K FileKF-06-21MM-6PK2026-07-21
00850085821188K FileKF-08-21MM-6PK2026-07-21
00850085821195K FileKF-10-21MM-6PK2026-07-21
00850085821201H FilesHF-15-21MM-6PK2026-07-21
00850085821003Legacy UniversalLU-SX-19MM-6PK2026-04-17
00850085821010Legacy FilesLF-21MM-6PK2026-04-17
00850085821027Legacy FilesLF-25MM-6PK2026-04-17
00850085821034Legacy FilesLF-31MM-6PK2026-04-17
00850085821041Canal Pro SystemCPS-21MM-6PK2026-04-17
00850085821058Canal Pro SystemCPS-25MM-6PK2026-04-17
00850085821065Canal Pro SystemCPS-31MM-6PK2026-04-17
00850085821072Canal EaseCE-21MM-6PK2026-04-17
00850085821089Canal EaseCE-25MM-6PK2026-04-17
00850085821096Scout FilesSF-014-21MM-6PK2026-04-17
00850085821102Scout FilesSF-015-21MM-6PK2026-04-17
00850085821119CET Gate DrillsGD-2-28MM-6PK2026-04-17
00850085821133CET Gutta Percha Points04GP-20-60PK2026-04-17
00850085821140CET Gutta Percha Points04GP-25-60PK2026-04-17
00850085821157CET Gutta Percha Points06GP-20-60PK2026-04-17
00850085821164CET Gutta Percha Points06GP-25-60PK2026-04-17

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