FDA.reportPublic FDA data

3DDX Sleeve 340-240-4L

Primary DI
00850073333679
Brand
3DDX Sleeve 340-240-4L
Company
3D DIAGNOSTIX, INC.
Model
Drilling template guide-sleeve /340-240-4L
Device description
A small tubular device intended to be inserted within the guide holes of a dental implantation drilling template (a device used to guide drilling in the jawbone during dental implant placement/fixation) to guide the implant into position. This is a single-use 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
Single use
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
00850073333679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850073333679008500733336798500733336790850073333679

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation drilling template guide-sleeveA small tubular device intended to be inserted within the guide holes of a dental implantation drilling template (a device used to guide drilling in the jawbone during dental implant placement/fixation) to guide the implant into position. This is a single-use device.

Regulatory Flags#

DUNS number
004512027
Device count
1
Premarket exempt
true
Lot or batch
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
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07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235565DRIVER RATCHET RETRIVER M1.6MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
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