FDA.reportPublic FDA data

Millennium

Primary DI
00190776365196
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
17-090323
Device description
Davis Root Tip Pick, #1
Published
2023-02-22
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
EMJELEVATOR, SURGICAL, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776365196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776365196001907763651961907763651960190776365196

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal pick/brush, reusableA manual, pointed, oral hygiene device with a soft tip or bristles intended to be used to stimulate and massage the gums to promote good periodontal (gum) condition, and to clean and remove plaque and debris from between the teeth and gingival surfaces. It may also be referred to as an interdental/interproximal brush and is intended for use in the home. 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
ESAM14447011STOMA®Storz am Mark GmbHEMJ2026-05-26
ESAM14447021STOMA®Storz am Mark GmbHEMJ2026-05-26
ESAM14447031STOMA®Storz am Mark GmbHEMJ2026-05-26
ESAM14447041STOMA®Storz am Mark GmbHEMJ2026-05-26
G149TBSB71010TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7720TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7730TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7740TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7750TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7760TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7770TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7780TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7790TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7800TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7810TBS BASICSACME ENTERPRISE.EMJ2026-05-22
G149TBSB7820TBS BASICSACME ENTERPRISE.EMJ2026-05-22
00348783004069Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004076Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004182Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00348783004229Premier ElevatorPREMIER DENTAL PRODUCTS COMPANYEMJ2026-03-17
00192896122772Winged ElevatorSONTEC INSTRUMENTS, INC.EMJ2026-03-10
00192896122789Winged ElevatorSONTEC INSTRUMENTS, INC.EMJ2026-03-10
G1493803201TBS DentalACME ENTERPRISE.EMJ2026-03-03
G1493803302TBS DentalACME ENTERPRISE.EMJ2026-03-03
G1493801502TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801704TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801805TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493801906TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802200TBS DentalACME ENTERPRISE.EMJ2026-03-02
G1493802301TBS DentalACME ENTERPRISE.EMJ2026-03-02