FDA.reportPublic FDA data

Straight Drill LSD 03.45x28 - Red

Primary DI
00850073333303
Brand
Straight Drill LSD 03.45x28 - Red
Company
3D DIAGNOSTIX, INC.
Model
Dental drill bit, reusable / Straight Drill LSD 03
Device description
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 appliance.
Published
2025-09-11
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850073333303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850073333303008500733333038500733333030850073333303

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.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
004512027
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850073333822AOX 3DDX KitDental implant suprastructure, temporary, preforme2026-09-22
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
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
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
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07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
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07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14