FDA.reportPublic FDA data

Millennium

Primary DI
00190776352066
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
9-22715
Device description
Dental Arch Bar
Published
2023-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHOBAR, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHOBar, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776352066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776352066001907763520661907763520660190776352066

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. 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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EZPF41905000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEHO2022-12-07
EZPF41905010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEHO2022-12-07
EZPF4190702S0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEHO2022-12-07
07630031724502NAInstitut Straumann AGEHO2022-11-10
07630031724519NAInstitut Straumann AGEHO2022-11-10
00842092112847HaderPreat CorporationEHO2022-10-24
00842092113103PreatPreat CorporationEHO2022-10-24
00842092129784PreatPreat CorporationEHO2022-10-24
00842092130834PreatPreat CorporationEHO2022-10-24
00842092131923PreatPreat CorporationEHO2022-10-24
00842092133224PreatPreat CorporationEHO2022-10-24
00842092133231PreatPreat CorporationEHO2022-10-24
00842092133330PreatPreat CorporationEHO2022-10-24
00842092133408PreatPreat CorporationEHO2022-10-24
00842092133576PreatPreat CorporationEHO2022-10-24
00842092134450PreatPreat CorporationEHO2022-10-24
00842092134467PreatPreat CorporationEHO2022-10-24
00842092134610PreatPreat CorporationEHO2022-10-24
00842092136522PreatPreat CorporationEHO2022-10-24
00842092139745PreatPreat CorporationEHO2022-10-24
00842092139769PreatPreat CorporationEHO2022-10-24
00842092139783PreatPreat CorporationEHO2022-10-24
00842092139806PreatPreat CorporationEHO2022-10-24
00842092139837PreatPreat CorporationEHO2022-10-24
00842092139851PreatPreat CorporationEHO2022-10-24
00842092139875PreatPreat CorporationEHO2022-10-24
00842092139882PreatPreat CorporationEHO2022-10-24
00842092139905PreatPreat CorporationEHO2022-10-24
00842092139929PreatPreat CorporationEHO2022-10-24
00842092139936PreatPreat CorporationEHO2022-10-24