FDA.reportPublic FDA data

3DDX Tapered Drill Kit

Primary DI
00850073333570
Brand
3DDX Tapered Drill Kit
Company
3D DIAGNOSTIX, INC.
Model
Dental/maxillofacial surgical procedure kit, non-m
Device description
A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.
Published
2025-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NYEFixture Mount Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYEFixture Mount KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850073333570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850073333570008500733335708500733335700850073333570

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
004512027
Device count
1
Premarket exempt
true
Kit
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
008500733335633DDX Straight Drill KitDental/maxillofacial surgical procedure kit, non-m2025-09-10
00850073333013Night Guard Printed Night Guard2025-09-11
00850073333136Straight Drill LSD 02.75x15 - BlackDental drill bit, reusable / Straight Drill LSD 022025-09-11
00850073333143Straight Drill LSD 02.75x18 - WhiteDental drill bit, reusable / Straight Drill LSD 022025-09-11
00850073333150Straight Drill LSD 02.75x20 - BlueDental drill bit, reusable / Straight Drill LSD 022025-09-11
00850073333167Straight Drill LSD 02.75x23 - GreenDental drill bit, reusable / Straight Drill LSD 022025-09-11
00850073333174Straight Drill LSD 02.75x25 - YellowDental drill bit, reusable / Straight Drill LSD 022025-09-11
00850073333198Straight Drill LSD 03.15x15 - BlackDental drill bit, reusable / Straight Drill LSD 032025-09-11
00850073333204Straight Drill LSD 03.15x18 - WhiteDental drill bit, reusable / Straight Drill LSD 032025-09-11
00850073333211Straight Drill LSD 03.15x20 - BlueDental drill bit, reusable / Straight Drill LSD 032025-09-11
00850073333228Straight Drill LSD 03.15x23 - GreenDental drill bit, reusable / Straight Drill LSD 032025-09-11
00850073333235Straight Drill LSD 03.15x25 - YellowDental drill bit, reusable / Straight Drill LSD 032025-09-11
00850073333242Straight Drill LSD 03.15x28 - RedDental drill bit, reusable / Straight Drill LSD 032025-09-11
00850073333259Straight Drill LSD 03.45x15 - BlackDental drill bit, reusable / Straight Drill LSD 032025-09-11
00850073333266Straight Drill LSD 03.45x18 - WhiteDental drill bit, reusable / Straight Drill LSD 032025-09-11
00850073333273Straight Drill LSD 03.45x20 - BlueDental drill bit, reusable / Straight Drill LSD 032025-09-11
00850073333280Straight Drill LSD 03.45x23 - GreenDental drill bit, reusable / Straight Drill LSD 032025-09-11
00850073333297Straight Drill LSD 03.45x25 - YellowDental drill bit, reusable / Straight Drill LSD 032025-09-11
00850073333303Straight Drill LSD 03.45x28 - RedDental drill bit, reusable / Straight Drill LSD 032025-09-11
00850073333310Straight Drill LSD 04.20x14 - BlackDental drill bit, reusable / Straight Drill LSD 042025-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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008500733335633DDX Straight Drill Kit3D DIAGNOSTIX, INC.NYE2025-09-10
08800271260286122 TAPER FULL KITOsstem Implant Co., Ltd.NYE2025-09-05
08800271260293122 TAPER KITOsstem Implant Co., Ltd.NYE2025-09-05
08800271260309485 KITOsstem Implant Co., Ltd.NYE2025-09-05
08800271260316TAPER KITOsstem Implant Co., Ltd.NYE2025-09-05
06947600302094TL MINI KITBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304388BL MINI KITBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304395BLT MINI KITBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304654BC Removal Kit,BCJJ-SBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304661BC Removal Kit,BCJJ-LBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600316350BV Removal Kit,BVJJ-LBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600316589BV MINI KitBIO CONCEPT Co., Ltd.NYE2025-03-25
08800271240516Bone Compaction KITOsstem Implant Co., Ltd.NYE2025-02-03
08800271241544Bone Compaction KITOsstem Implant Co., Ltd.NYE2025-02-03
08800271234409OneArch KITOsstem Implant Co., Ltd.NYE2025-01-03
08800271229733485 KITOsstem Implant Co., Ltd.NYE2024-12-10
08800271233976OneArch KITOsstem Implant Co., Ltd.NYE2024-12-09
06947600319948BV Standard KlTBIO CONCEPT Co., Ltd.NYE2024-11-27
08800271219987Bone Compaction KITOsstem Implant Co., Ltd.NYE2024-09-26
08800271219994Bone Compaction KITOsstem Implant Co., Ltd.NYE2024-09-26
06947600316596BV Guided Kit,BVBIO CONCEPT Co., Ltd.NYE2024-09-18
08800271225438SIMPLE KITOsstem Implant Co., Ltd.NYE2024-09-10
08800271218409Taper Ultra KITOsstem Implant Co., Ltd.NYE2024-08-20
08800271218416Taper Ultra KITOsstem Implant Co., Ltd.NYE2024-08-20
08809917070012122 Taper Full KITOsstem Implant Co., Ltd.NYE2024-08-20
08809917070029122 Taper KITOsstem Implant Co., Ltd.NYE2024-08-20
08809917070036123 Straight KITOsstem Implant Co., Ltd.NYE2024-08-20
08809917070043123 Straight Simple KITOsstem Implant Co., Ltd.NYE2024-08-20