FDA.reportPublic FDA data

Avalign

Primary DI
00190776376819
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM98-2213
Device description
Peritome, double ended, straight blade,
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
EMKCURETTE, SURGICAL, DENTAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776376819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776376819001907763768191907763768190190776376819

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. 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
G149TBSB7900TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7910TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7920TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7930TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7940TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149TBSB7950TBS BASICSACME ENTERPRISE.EMK2026-05-21
G149NP380620NPSACME ENTERPRISE.EMK2026-05-01
G149NPSCL0NPSACME ENTERPRISE.EMK2026-05-01
10889950126339Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126346Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126353Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126360Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126377Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126384Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126391Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126407Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126414Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
10889950126421Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMK2026-04-06
00348783007770Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007787Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007794Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007800Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007817Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007824Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00348783007848Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-04-02
00192896122444Gracey CuretteSONTEC INSTRUMENTS, INC.EMK2025-10-28
00192896119758Gracey CuretteSONTEC INSTRUMENTS, INC.EMK2024-09-05
00813677025135PDT, Inc.PDT, INC.EMK2024-08-12
B382SD9348330830Surgical DirectSurgical Direct, Inc.EMK2024-07-11
00813677024497PDT, Inc.PDT, INC.EMK2024-06-27