FDA.reportPublic FDA data

Avalign

Primary DI
00190776075019
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM99-1355
Device description
Lucas Curette
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKTCURETTE, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKTCurette, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776075019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776075019001907760750191907760750190190776075019

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal file/rasp, manualA hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a one-piece instrument 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 made of metal [e.g., stainless steel, titanium (Ti)]. This device is typically used to remove gross supragingival calculus, smooth the cementoenamel junction (CEJ), and remove overhanging margins of dental restorations. 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
00190776391560CONDUIT ZERO-P VA4514010602026-07-09
00190776391577CONDUIT ZERO-P VA4514010702026-07-09
00190776391584CONDUIT ZERO-P VA4514010802026-07-09
00190776391591CONDUIT ZERO-P VA4514010902026-07-09
00190776391607CONDUIT ZERO-P VA4514011002026-07-09
00190776391614CONDUIT ZERO-P VA4514011102026-07-09
00190776391621CONDUIT ZERO-P VA4514011202026-07-09
00190776391638CONDUIT ZERO-P VA4514020502026-07-09
00190776391645CONDUIT ZERO-P VA4514020602026-07-09
00190776391652CONDUIT ZERO-P VA4514020702026-07-09
00190776391669CONDUIT ZERO-P VA4514020802026-07-09
00190776391676CONDUIT ZERO-P VA4514020902026-07-09
00190776391553CONDUIT ZERO-P VA4514010502026-07-08
00190776421847Millennium1-3KF-52026-06-25
00190776421694Millennium72-24655152026-06-24
00190776421700Millennium1-1701922026-06-24
00190776421717Millennium1-1701942026-06-24
00190776421724Millennium1-77ST42026-06-24
00190776421731Millennium72-5211303C2026-06-24
00190776421748Millennium1-343003H2026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB2060TBS BASICSACME ENTERPRISE.EKT2026-05-16
G149TBSB2070TBS BASICSACME ENTERPRISE.EKT2026-05-16
G149TBSB2080TBS BASICSACME ENTERPRISE.EKT2026-05-16
G149TBSB2090TBS BASICSACME ENTERPRISE.EKT2026-05-16
00810123209682Adler Instrument CompanyAdler, Inc.EKT2025-12-08
00190776410643MillenniumAvalign Technologies, Inc.EKT2025-09-11
00190776409166MillenniumAvalign Technologies, Inc.EKT2025-08-22
00190776405304MillenniumAvalign Technologies, Inc.EKT2025-07-15
00810123208340Adler Instrument CompanyAdler, Inc.EKT2025-01-27
00614950031405ACEACE SURGICAL SUPPLY CO., INC.EKT2023-12-05
00190776075002AvalignAvalign Technologies, Inc.EKT2023-11-13
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