FDA.report

Millennium

Primary DI
00190776405304
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-MO11022
Device description
Exodontia Oral Curette Molt OL 175mm (6 3/4") #5L
Published
2025-07-15
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

Related Records

Contact Domains

Product Codes

CodeName
EKTCurette, Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKTCurette, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776405304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776405304001907764053041907764053040190776405304

GMDN Terms

TermDefinition
General-purpose curetteA hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
00810123209682Adler Instrument CompanyAdler, Inc.EKT2025-12-08
00190776410643MillenniumAvalign Technologies, Inc.EKT2025-09-11
00190776409166MillenniumAvalign Technologies, Inc.EKT2025-08-22
00810123208340Adler Instrument CompanyAdler, Inc.EKT2025-01-27
00614950031405ACEACE SURGICAL SUPPLY CO., INC.EKT2023-12-05
00190776075002AvalignAvalign Technologies, Inc.EKT2023-11-13
00190776075019AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287412AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287429AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287436AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287498AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776351359MILLENNIUMAvalign Technologies, Inc.EKT2023-09-28
00190776372606AvalignAvalign Technologies, Inc.EKT2023-09-28
00810123202362Adler Instrument CompanyAdler, Inc.EKT2023-03-16
00190776363277MillenniumAVALIGN TECHNOLOGIES, INC.EKT2023-02-22
00190776363284MillenniumAVALIGN TECHNOLOGIES, INC.EKT2023-02-22
00190776363291MillenniumAVALIGN TECHNOLOGIES, INC.EKT2023-02-22
00190776363307MillenniumAVALIGN TECHNOLOGIES, INC.EKT2023-02-22
00190776363314MillenniumAVALIGN TECHNOLOGIES, INC.EKT2023-02-22
00190776363321MillenniumAVALIGN TECHNOLOGIES, INC.EKT2023-02-22
00190776363338MillenniumAVALIGN TECHNOLOGIES, INC.EKT2023-02-22
00190776363345MillenniumAVALIGN TECHNOLOGIES, INC.EKT2023-02-22
00190776363352MillenniumAVALIGN TECHNOLOGIES, INC.EKT2023-02-22
00190776363369MillenniumAVALIGN TECHNOLOGIES, INC.EKT2023-02-22
00190776363376MillenniumAVALIGN TECHNOLOGIES, INC.EKT2023-02-22
00190776363383MillenniumAVALIGN TECHNOLOGIES, INC.EKT2023-02-22
00190776363390MillenniumAVALIGN TECHNOLOGIES, INC.EKT2023-02-22
14026704803382PILLINGTELEFLEX INCORPORATEDEKT2022-12-08
54026704803397PILLINGTELEFLEX INCORPORATEDEKT2022-12-08
14026704803436PILLINGTELEFLEX INCORPORATEDEKT2022-12-08