FDA.reportPublic FDA data

Millennium

Primary DI
00190776426743
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-686102
Device description
Lindman Drill #2, 65mm
Published
2026-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776426743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776426743001907764267431907764267430190776426743

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776417116Millennium85-170103022026-08-19
00190776417123Millennium85-170103072026-08-19
00190776417130Millennium85-150210582026-08-19
00190776417147Millennium85-200817712026-08-19
00190776417154Millennium85-770057162026-08-19
00190776417161Millennium85-538056882026-08-19
00190776417178Millennium85-320071642026-08-19
00190776417192Millennium85-780866482026-08-19
00190776417208Millennium85-330848342026-08-19
00190776417215Millennium85-330848142026-08-19
00190776417222Millennium85-330848192026-08-19
00190776417239Millennium85-638014582026-08-19
00190776417246Millennium85-230826882026-08-19
00190776417253Millennium85-230811872026-08-19
00190776417710Millennium85-230811922026-08-19
00190776417727Millennium85-124162352026-08-19
00190776426569Millennium1-466322026-08-19
00190776426576Millennium92-F1750T2026-08-19
00190776426583Millennium1-911-52026-08-19
00190776426590Millennium1-910-52026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426736MillenniumAvalign Technologies, Inc.EJL2026-08-19
04099797000726Drill for CT-tubeALTATEC GmbHEJL2026-08-17
04099797000733Drill for CT-tubeALTATEC GmbHEJL2026-08-17
04099797010664Surgery set CERALOG® PROGRESSIVE-LINE FlexALTATEC GmbHEJL2026-08-17
04099797011661Guide Template drillALTATEC GmbHEJL2026-08-17
04099797011678Guide Template drillALTATEC GmbHEJL2026-08-17
04099797011920Drill extensionALTATEC GmbHEJL2026-08-17
04099797012026Depth stopALTATEC GmbHEJL2026-08-17
04099797012033Depth stopALTATEC GmbHEJL2026-08-17
04099797012040Depth stopALTATEC GmbHEJL2026-08-17
04099797012057Depth stopALTATEC GmbHEJL2026-08-17
04099797012064Depth stopALTATEC GmbHEJL2026-08-17
04099797012071Depth stopALTATEC GmbHEJL2026-08-17
04099797012088Depth stopALTATEC GmbHEJL2026-08-17
04099797012095Depth stopALTATEC GmbHEJL2026-08-17
04099797012101Depth stopALTATEC GmbHEJL2026-08-17
04099797012118Point drillALTATEC GmbHEJL2026-08-17
04099797012125SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012132SCREW-LINE TapALTATEC GmbHEJL2026-08-17
04099797012354Pilot drill SetALTATEC GmbHEJL2026-08-17
04099797012361Pilot drill SetALTATEC GmbHEJL2026-08-17
04099797012378SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012385SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012392SCREW-LINE Form drillALTATEC GmbHEJL2026-08-17
04099797012408PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012415PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012422PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012439PROGRESSIVE-LINE Dense bone drillALTATEC GmbHEJL2026-08-17
04099797012446PROGRESSIVE-LINE Dense bone drill 2ALTATEC GmbHEJL2026-08-17
04099797012453PROGRESSIVE-LINE Dense bone drill 2ALTATEC GmbHEJL2026-08-17