FDA.reportPublic FDA data

Health-Tec/DHP Matrix Bands

Primary DI
D773800100011
Brand
Health-Tec/DHP Matrix Bands
Company
Dental Health Products Inc
Model
800-10001
Catalog number
800-10001
Device description
"Health-Tec/DHP Matrix Bands #1 - .0015"" 12/pkg"
Published
2022-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EKFInstrument, Contouring, Matrix, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKFInstrument, Contouring, Matrix, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D773800100011PrimaryHIBCC0
D773800100010Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental matrix band, single-useA band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
623191194
Device count
12
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D773210HT40A121DHP Nanohybrid Composite210-HT40A12210-HT40A122022-10-20
D773210HT40A221DHP Nanohybrid Composite210-HT40A22210-HT40A222022-10-20
D773210HT40A321DHP Nanohybrid Composite210-HT40A32210-HT40A322022-10-20
D773210HT40A3521DHP Nanohybrid Composite210-HT40A352210-HT40A3522022-10-20
D773210HT40B121DHP Nanohybrid Composite210-HT40B12210-HT40B122022-10-20
D773210HT40B221DHP Nanohybrid Composite210-HT40B22210-HT40B222022-10-20
D773210HT40C221DHP Nanohybrid Composite210-HT40C22210-HT40C222022-10-20
D773210HT40C321DHP Nanohybrid Composite210-HT40C32210-HT40C322022-10-20
D773210HT50A120DHP Nanohybrid Composite210-HT50A12210-HT50A122022-10-20
D773210HT50A220DHP Nanohybrid Composite210-HT50A22210-HT50A222022-10-20
D773210HT50A320DHP Nanohybrid Composite210-HT50A32210-HT50A322022-10-20
D773210HT50A3520DHP Nanohybrid Composite210-HT50A352210-HT50A3522022-10-20
D773210HT50B120DHP Nanohybrid Composite210-HT50B12210-HT50B122022-10-20
D773210HT50C320DHP Nanohybrid Composite210-HT50C32210-HT50C322022-10-20
D773210HT10A121DHP Nanohybrid Flowable Composite210-HT10A12210-HT10A122022-10-19
D773210HT10A221DHP Nanohybrid Flowable Composite210-HT10A22210-HT10A222022-10-19
D773210HT10A321DHP Nanohybrid Flowable Composite210-HT10A32210-HT10A322022-10-19
D773210HT10A3521DHP Nanohybrid Flowable Composite210-HT10A352210-HT10A3522022-10-19
D773210HT10A421DHP Nanohybrid Flowable Composite210-HT10A42210-HT10A422022-10-19
D773210HT10B121DHP Nanohybrid Flowable Composite210-HT10B12210-HT10B122022-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07897990399091UNIMATRIX STDV DENTAL LTDAEKF2026-02-18
07897990399213UNIMATRIX STDV DENTAL LTDAEKF2026-02-18
07897990399220UNIMATRIX STDV DENTAL LTDAEKF2026-02-18
07897990301919METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990301940METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990306297METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990306303METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990308611METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990308628METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990301636PREMOLAR MATRICESTDV DENTAL LTDAEKF2025-02-28
07897990301643MOLAR MATRICESTDV DENTAL LTDAEKF2025-02-28
07897990301650DECIDUOUS MATRICESTDV DENTAL LTDAEKF2025-02-28
07897990301681METALLIC MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301698METALLIC MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301797UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301803UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301810UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301827UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301841UNIMATRIX PLIERTDV DENTAL LTDAEKF2025-02-28
07897990301872TOFFLEMIRE MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301889TOFFLEMIRE MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301896TOFFLEMIRE MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301902POLYESTER MATRIX STRIPTDV DENTAL LTDAEKF2025-02-28
07897990301926METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-02-28
07897990301933METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-02-28
07897990306662UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990306679UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990306686UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990306693UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990308581POLYESTER MATRIX STRIPTDV DENTAL LTDAEKF2025-02-28