FDA.reportPublic FDA data

Straight Drill LSD 02.75x15 - Black

Primary DI
00850073333136
Brand
Straight Drill LSD 02.75x15 - Black
Company
3D DIAGNOSTIX, INC.
Model
Dental drill bit, reusable / Straight Drill LSD 02
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
00850073333136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850073333136008500733331368500733331360850073333136

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
008500733335633DDX Straight Drill KitDental/maxillofacial surgical procedure kit, non-m2025-09-10
00850073333013Night Guard Printed Night Guard2025-09-11
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
00850073333327Straight Drill LSD 04.20x17 - WhiteDental drill bit, reusable / Straight Drill LSD 042025-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013189MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013239MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013289MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013369MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013389MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013399MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013509MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013599MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013609MEDENTiKAMEDENTiKA GmbHNDP2020-04-08