FDA.reportPublic FDA data

Millennium

Primary DI
00190776405229
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-MO10053
Device description
"ORAL BONE FILE CROSSCUT 7""OL"
Published
2025-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMIFile, Bone, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMIFile, Bone, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776405229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776405229001907764052291907764052290190776405229

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776435080Millennium1-2122402026-10-15
00190776435097Millennium1-2126602026-10-15
00190776435103Millennium1-4201262026-10-15
00190776435110Millennium1-4201252026-10-15
00190776435127Millennium1-4103012026-10-15
00190776435134Millennium1-4103022026-10-15
00190776061890Avalign TechnologiesVM8014112026-10-14
00190776434885Millennium92-F2012R52026-10-14
00190776434892Millennium92-1162026-10-14
00190776434908Millennium92-C05432026-10-14
00190776434915Millennium1-302103TC2026-10-14
00190776434922Millennium72-5220574L2026-10-14
00190776434939Millennium92-H0620RT2026-10-14
00190776434946Millennium72-4296669282026-10-14
00190776434953Millennium1-3636202026-10-14
00190776434960Millennium1-3231E2026-10-14
00190776434977Millennium72-42890302026-10-14
00190776434984Millennium92-F23092026-10-14
00190776434991Millennium92-H02592026-10-14
00190776435004Millennium1-OBSPOON2026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840105223856ZOLL DENTALZoll-DentalEMI2026-08-18
G879106214H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMI2026-08-08
G879106216H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMI2026-08-08
G879106217H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMI2026-08-08
G879106218H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMI2026-08-08
00348783010053Premier FilePREMIER DENTAL PRODUCTS COMPANYEMI2026-04-27
00840018672642Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-11
00840018663589Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-04
00840018665514Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-04
00840018662476Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00840018662858Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00840018663220Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00194613115968MSI Precision Specialty InstrumentsMed Saver, Inc.EMI2025-08-01
00889813066874Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEMI2025-02-12
00889813066881Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEMI2025-02-12
00840306823619Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EMI2025-01-17
00840306823626Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EMI2025-01-17
00813677025135PDT, Inc.PDT, INC.EMI2024-08-12
06974456210761CICADAFoshan Cicada Dental Instrument Co., Ltd.EMI2024-08-10
86974456210767CICADAFoshan Cicada Dental Instrument Co., Ltd.EMI2024-08-10
00813677024558PDT, Inc.PDT, INC.EMI2024-07-03
00813677024497PDT, Inc.PDT, INC.EMI2024-06-27
00190776388911AvalignAvalign Technologies, Inc.EMI2024-05-15
00842517105638Karl SchumacherKarl Schumacher Dental, LLCEMI2024-03-18
00842517105645Karl SchumacherKarl Schumacher Dental, LLCEMI2024-03-18
00888515225336BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
00888515225374BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
00888515225497BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
08800075612892OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-27
08800075612908OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-27