FDA.reportPublic FDA data

Nivo

Primary DI
08964003163280
Brand
Nivo
Company
B. Ali Impex
Model
NTRAU
Device description
Tofflemire Matrix Retainer Adult Universal
Published
2024-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
JEPRetainer, Matrix

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08964003163280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08964003163280089640031632808964003163280

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band retainerA dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration. It can be designed as a self-closing circular ring, or a rod-like instrument that tensions and locks the matrix band in place. This device will remain intraoral or attached to the matrix band during the dental procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645802117
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08964003163853Doctor Nice786-28L102024-01-29
08964003163860Doctor Nice786-30L102024-01-29
08964003163877Doctor Nice786-04G32024-01-29
08964003163884Doctor Nice786-04L2024-01-29
08964003163891Doctor Nice786-03L2024-01-29
08964003163075Doctor Nice786-14786-142023-11-10
08964003163112Doctor Nice786-14G42023-11-10
08964003163129Doctor Nice786-33G22023-11-10
08964003163136Doctor Nice786-34G22023-11-10
08964003163143Doctor Nice786-14G52023-11-10
08964003163020Doctor Nice786-012023-11-09
08964003163037Doctor Nice786-022023-11-09
08964003163051Doctor Nice786-032023-11-09
08964003163068Doctor Nice786-152023-11-09
08964003163082Doctor Nice786-15/G22023-11-09
08964003163099Doctor Nice786-14/G22023-11-09
08964003163105Doctor Nice786-15G42023-11-09
08964003163150Doctor Nice786-04LB2023-11-09
08964003163167Doctor Nice786-282023-11-09
08964003163174Doctor Nice786-302023-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB1380TBS BASICSACME ENTERPRISE.JEP2026-05-20
G149TBSB1420TBS BASICSACME ENTERPRISE.JEP2026-05-20
G149TBSB1430TBS BASICSACME ENTERPRISE.JEP2026-05-20
10304040193904Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193911Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193928Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
10304040193935Henry ScheinHENRY SCHEIN, INC.JEP2025-10-15
20686864061155MEDICOM SAFEMATRIXAMD Medicom IncJEP2025-03-18
10686864060649MEDICOM SAFEMATRIXAMD Medicom IncJEP2024-04-09
10686864060656MEDICOM SAFEMATRIXAMD Medicom IncJEP2024-04-09
10810038090495Strata-G™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090501Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090518Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090525Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090532Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090549Strata-G™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090556Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
10810038090563Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090492Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090508Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090515Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090522Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
20810038090539Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.JEP2023-02-14
M752ZZ14080STRADIS HEALTHCARESTRADIS MEDICAL, LLCJEP2022-04-29
10686864056482MEDICOM SAFEMATRIXAMD Medicom IncJEP2021-04-27
10686864056499MEDICOM SAFEMATRIX CONTOURAMD Medicom IncJEP2021-04-27
10686864057151MEDICOM SAFEMATRIXAMD Medicom IncJEP2021-04-27
10686864057168MEDICOM SAFEMATRIX CONTOURAMD Medicom IncJEP2021-04-27
10304040142803Henry ScheinHENRY SCHEIN, INC.JEP2021-03-12
10304040142827Henry ScheinHENRY SCHEIN, INC.JEP2021-03-12