FDA.reportPublic FDA data

Health-Tec Ultra Digital X-Ray Sensor Sheaths

Primary DI
D7736609185001
Brand
Health-Tec Ultra Digital X-Ray Sensor Sheaths
Company
Dental Health Products Inc
Model
660-918500
Catalog number
660-918500
Device description
Health-Tec Ultra Digital X-Ray Sensor Sheaths, Size 1
Published
2017-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PEMDental Barriers And Sleeves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7736609185003PackageHIBCC20In Commercial Distribution
D7736609185001PrimaryHIBCC0
D7736609185000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental bibA non-sterile device intended to be worn by a patient during a dental examination or treatment procedure to function as a barrier to soiling and cross-contamination. It typically consists of a shaped piece of natural and/or synthetic material intended to be fastened around the neck and cover the front side of the upper body. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-626-2163mhull@dhpi.net

Regulatory Flags#

DUNS number
623191194
Device count
500
Lot or batch
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

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Primary DI, Brand, Company table
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10618125192301CarinaTIDI PRODUCTS, LLCPEM2025-09-22
00618125187126VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125187133VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125187140VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188710VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188727VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125188734VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125189953VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125190171VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125190188VALOTIDI PRODUCTS, LLCPEM2025-08-29
20665973031815UnipackDukal LLCPEM2025-03-20
20665973031822UnipackDukal LLCPEM2025-03-20
20665973031839UnipackDukal LLCPEM2025-03-20
10304040186722AccleanHENRY SCHEIN, INC.PEM2024-10-02
00816577024581Young InfinityYoung Innovations, Inc.PEM2024-09-30
00816577024604DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
00816577024611DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
00816577024628DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
00816577024635DenticatorYOUNG DENTAL MANUFACTURING I, LLCPEM2024-09-30
20850061028024Dental BasicsDental Basics Inc.PEM2024-05-08
10371347011941Advance Dental ProductsThe Atlanta Dental Supply CompanyPEM2024-01-04
10371347011958Advance Dental ProductsThe Atlanta Dental Supply CompanyPEM2024-01-04
00816419021617iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021624iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021853iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021860iSmileIsmile Dental Products, Inc.PEM2023-06-21
00816419021877iSmileIsmile Dental Products, Inc.PEM2023-06-21