FDA.reportPublic FDA data

3D Dental

Primary DI
00817169024880
Brand
3D Dental
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
MTL
Catalog number
MTL
Device description
MIXING TIP CROWN AND BRIDGE BLUE & ORANGE BAG OF 50
Published
2023-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MTLMonitor,Test,Hiv-1

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTLMonitor,Test,Hiv-1Unknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817169024887PackageGS150In Commercial Distribution
00817169024880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081716902488710817169024887
00817169024880008171690248808171690248800817169024880

GMDN Terms#

Term, Definition table
TermDefinition
Dental material mixing nozzleA device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080194935
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810126508362Essentials By 3D DentalGN300-L2026-04-16
008101265062213D DentalRCPC2026-03-24
00810126506757Comfortox5CC30132026-03-24
00810126506764Comfortox5CC2982026-03-24
00810126508355Basik by 3D DentalBPGLA4672026-03-17
00810126508331Basik by 3D DentalBPGC9422026-03-17
00810126508348Basik by 3D DentalBPGC9432026-03-17
10817169023019Basik by 3D DentalBPGLA4672026-03-17
008171690214833D Dental - DreamDFVMLDFVML2023-01-11
00817169023005Basik by 3D DentalBPGLA4532026-03-17
00810126506054The Essentials By 3D DentalPL-HCSPL-HCS2023-02-28
00810126506061The Essentials By 3D DentalPL-HRLGPL-HRLG2023-02-28
008171690201723D Dental - DreamDFVBG2016-12-12
008171690201893D Dental - DreamDFVSM2016-12-12
008171690214763D Dental-DreamDFVCM2017-12-04
008171690219643D Dental- BiovivaBHG2018-08-30
008101265081643D DentalJSM-CN2026-03-16
008101265081713D DentalJSM-CW2026-03-16
008101265081883D DentalJSM-N2026-03-16
008101265081953D DentalJSM-W2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00875197000993COBAS AMPLICOR HIV-1 Monitor Test, version 1.5Roche Molecular Systems, Inc.MTL2014-09-17
00608337000016OraQuick Advance Rapid HIV 1/2 Antibody TestOrasure Technologies, Inc.MTL2014-09-05
00608337000009OraQuick Advance HIV 1/2 Kit ControlsOrasure Technologies, Inc.MTL2014-09-05
20608337000010OraQuick Advance Rapid HIV 1/2 Antibody TestOrasure Technologies, Inc.MTL2014-09-05