FDA.reportPublic FDA data

Millennium

Primary DI
00190776383138
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-678342
Device description
Angled Ball Hook Crimping Pliers
Published
2024-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEXPlier, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776383138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776383138001907763831381907763831380190776383138

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic pliersA hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. 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
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD91427410030Surgical DirectSurgical Direct, Inc.JEX2026-02-09
B382SD9142761200Surgical DirectSurgical Direct, Inc.JEX2026-02-09
00190746065477Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
00190746065507Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
00190746067426Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
00190746067440Luno PliersAMERICAN ORTHODONTICS CORPORATIONJEX2026-01-28
10190707086494Triumph®Ortho Organizers, Inc.JEX2026-01-07
00190707086503Triumph®Ortho Organizers, Inc.JEX2026-01-07
10190707086517Triumph®Ortho Organizers, Inc.JEX2026-01-07
10190707086524Triumph®Ortho Organizers, Inc.JEX2026-01-07
10190707086531Triumph®Ortho Organizers, Inc.JEX2026-01-07
D9098000041SPECTRUMOrtho Arch Company IncJEX2025-09-15
D909800022S1SPECTRUMOrtho Arch Company IncJEX2025-09-15
D909800063C1SPECTRUMOrtho Arch Company IncJEX2025-09-15
D909800063L1ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D90980007214ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D90980008417SPECTRUMOrtho Arch Company IncJEX2025-09-15
D90980008518SPECTRUMOrtho Arch Company IncJEX2025-09-15
D90980023515RAZOROrtho Arch Company IncJEX2025-09-15
D90980023919RAZOROrtho Arch Company IncJEX2025-09-15
D909800239T1RAZOROrtho Arch Company IncJEX2025-09-15
D90980024011RAZOROrtho Arch Company IncJEX2025-09-15
D90980024112RAZOROrtho Arch Company IncJEX2025-09-15
D90980024213RAZOROrtho Arch Company IncJEX2025-09-15
D9098002761ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D9098002771ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D9098002781ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D9098002791ORTHO ARCHOrtho Arch Company IncJEX2025-09-15
D90980013817ORTHO ARCHOrtho Arch Company IncJEX2025-08-27
04963931274291NAYDM CORPORATIONJEX2025-07-11